Practice Alert

Recently, the US Preventive Services Task Force (USPSTF) finalized 7 recommendations on 5 topics and posted draft recommendations on an additional 10 topics. It also implemented new procedures that include posting draft recommendations for public comment (see “A new review process for the USPSTF”). This article reviews the USPSTF activity in 2011, as well as cervical cancer screening recommendations issued earlier this year.

2012 recommendations

Screening for cervical cancer
The USPSTF released its new recommendations on screening for cervical cancer in March (TABLE 1).¹ The final document varied from the 2011 draft recommendations in 2 areas: the roles of human papillomavirus (HPV) testing and sexual history.

1. The draft issued an I statement (insufficient evidence) for the role of HPV testing. Subsequently, based on stakeholder and public comment (as well as a review of 2 large recently published studies), the USPSTF gave an A recommendation to the use of HPV testing in conjunction with cervical cytology as an option for women ages 30 years and older who want to increase the interval between screening to 5 years.^2,3
2. The draft stated that the age at which screening should be initiated depends on a patient’s sexual history. The final recommendations state that screening should not begin until age 21, regardless of sexual history.

TABLE 1

These new recommendations balance the proven benefits of cervical cytology with the harms from overscreening and are now essentially the same as those of other organizations, including the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology. They differ in minor ways from those of the American Congress of Obstetricians and Gynecologists, and the American Academy of Family Physicians is assessing whether to endorse them.

Importantly, the new recommendations identify individuals for whom cervical cytology should be avoided—women younger than age 21, most women older than age 65, and those who have had a hysterectomy with removal of the cervix. A decision to stop screening after the 65th birthday depends on whether the patient has had adequate screening yielding normal findings: This is defined by the USPSTF as 3 consecutive negative cytology results (or 2 consecutive negative co-test results with cytology and HIV testing) within 10 years of the proposed time of cessation, with the most recent test having been performed within 5 years. Avoiding cytology testing after hysterectomy is contingent on the procedure having been performed for an indication other than a high-grade precancerous lesion or cervical cancer. In addition, the recommendations advise against HPV testing in women younger than age 30, as it offers little advantage and leads to much overdiagnosis.

Liquid vs conventional cytology. As a minor point, the USPSTF says the evidence clearly shows that liquid cytology offers no advantage over conventional cytology. But it recognizes that the screening method used is often not determined by the physician.

Recommendations finalized in 2011

TABLE 2 summarizes recommendations completed by the USPSTF last year.

Neonatal gonococcal eye infection prevention
The recommendation to use topical medication (erythromycin ointment) to prevent neonatal gonococcal eye infection is an update and reaffirmation of a previous recommendation. Blindness due to this disease has become rare in the United States because of the routine use of a neonatal topical antibiotic, and there is good evidence that it causes no significant harm. Its use continues to be recommended for all newborns.⁴

TABLE 2

Vision screening for children
Vision screening for preschool children can detect visual acuity problems such as amblyopia and refractive errors. A variety of screening tests are available, including visual acuity, stereoacuity, cover-uncover, Hirschberg light reflex, and auto-refractor tests (automated optical instruments that detect refractive errors). The most benefit is obtained by discovering and correcting amblyopia.

There is no evidence that detecting problems before age 3 years leads to better outcomes than detection between 3 and 5 years of age. Testing is more difficult in younger children and can yield inconclusive or false-positive results more frequently. This led the USPSTF to reaffirm vision testing once for children ages 3 to 5 years, and to state that the evidence is insufficient to make a recommendation for younger children.⁵

Screening for osteoporosis
The recommendations indicate that all women ages 65 and older should undergo screening, although the optimal frequency of screening is not known. The clinical discussion accompanying the recommendation indicates there is reason to believe that screening men may reduce morbidity and mortality, but that sufficient evidence for or against this is lacking.⁶

Screening can be done with dual-energy x-ray absorptiometry (DEXA) of the hip and lumbar spine, or quantitative ultrasonography of the calcaneus. DEXA is most commonly used, and is the basis for most treatment recommendations.

The recommendation to screen some women younger than 65 years, based on risk, is somewhat complex. The USPSTF recommends screening younger women if their 10-year risk of fracture is comparable to that of a 65-year-old white woman with no additional risk factors (a risk of 9.3% over 10 years). To calculate that risk, the USPSTF recommends using the FRAX (Fracture Risk Assessment) tool developed by the World Health Organization Collaborating Centre for Metabolic Bone Diseases, Sheffield, United Kingdom, which is available free to clinicians and the public (www.shef.ac.uk/FRAX/).

Screening for testicular cancer
The recommendation against screening for testicular cancer may surprise many physicians, even though it is a reaffirmation of a previous recommendation. Testicular cancer is uncommon (5 cases per 100,000 males per year) and treatment is successful in a large proportion of patients, regardless of the stage at which it is discovered. Patients or their partners discover these tumors in time for a cure and there is no evidence physician exams improve outcomes. Physician discovery of incidental and inconsequential findings such as spermatoceles and varicoceles can lead to unnecessary testing and follow-up.⁷

Screening for bladder cancer
The USPSTF issued an I statement for bladder cancer screening because there is little evidence regarding the diagnostic accuracy of available tests (urinalysis for microscopic hematuria, urine cytology, or tests for urine biomarkers) in detecting bladder cancer in asymptomatic patients. In addition, there is no evidence regarding the potential benefits of detecting asymptomatic bladder cancer.⁸

Current draft recommendations

The USPSTF posts recommendations on its Web site for public comment for 30 days. To see current draft recommendations, go to http://www.uspreventiveservicestaskforce.org/tfcomment.htm.

Recently, the US Preventive Services Task Force (USPSTF) finalized 7 recommendations on 5 topics and posted draft recommendations on an additional 10 topics. It also implemented new procedures that include posting draft recommendations for public comment (see “A new review process for the USPSTF”). This article reviews the USPSTF activity in 2011, as well as cervical cancer screening recommendations issued earlier this year.

2012 recommendations

Screening for cervical cancer
The USPSTF released its new recommendations on screening for cervical cancer in March (TABLE 1).¹ The final document varied from the 2011 draft recommendations in 2 areas: the roles of human papillomavirus (HPV) testing and sexual history.

1. The draft issued an I statement (insufficient evidence) for the role of HPV testing. Subsequently, based on stakeholder and public comment (as well as a review of 2 large recently published studies), the USPSTF gave an A recommendation to the use of HPV testing in conjunction with cervical cytology as an option for women ages 30 years and older who want to increase the interval between screening to 5 years.^2,3
2. The draft stated that the age at which screening should be initiated depends on a patient’s sexual history. The final recommendations state that screening should not begin until age 21, regardless of sexual history.

TABLE 1

These new recommendations balance the proven benefits of cervical cytology with the harms from overscreening and are now essentially the same as those of other organizations, including the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology. They differ in minor ways from those of the American Congress of Obstetricians and Gynecologists, and the American Academy of Family Physicians is assessing whether to endorse them.

Importantly, the new recommendations identify individuals for whom cervical cytology should be avoided—women younger than age 21, most women older than age 65, and those who have had a hysterectomy with removal of the cervix. A decision to stop screening after the 65th birthday depends on whether the patient has had adequate screening yielding normal findings: This is defined by the USPSTF as 3 consecutive negative cytology results (or 2 consecutive negative co-test results with cytology and HIV testing) within 10 years of the proposed time of cessation, with the most recent test having been performed within 5 years. Avoiding cytology testing after hysterectomy is contingent on the procedure having been performed for an indication other than a high-grade precancerous lesion or cervical cancer. In addition, the recommendations advise against HPV testing in women younger than age 30, as it offers little advantage and leads to much overdiagnosis.

Liquid vs conventional cytology. As a minor point, the USPSTF says the evidence clearly shows that liquid cytology offers no advantage over conventional cytology. But it recognizes that the screening method used is often not determined by the physician.

Recommendations finalized in 2011

TABLE 2 summarizes recommendations completed by the USPSTF last year.

Neonatal gonococcal eye infection prevention
The recommendation to use topical medication (erythromycin ointment) to prevent neonatal gonococcal eye infection is an update and reaffirmation of a previous recommendation. Blindness due to this disease has become rare in the United States because of the routine use of a neonatal topical antibiotic, and there is good evidence that it causes no significant harm. Its use continues to be recommended for all newborns.⁴

TABLE 2

Vision screening for children
Vision screening for preschool children can detect visual acuity problems such as amblyopia and refractive errors. A variety of screening tests are available, including visual acuity, stereoacuity, cover-uncover, Hirschberg light reflex, and auto-refractor tests (automated optical instruments that detect refractive errors). The most benefit is obtained by discovering and correcting amblyopia.

There is no evidence that detecting problems before age 3 years leads to better outcomes than detection between 3 and 5 years of age. Testing is more difficult in younger children and can yield inconclusive or false-positive results more frequently. This led the USPSTF to reaffirm vision testing once for children ages 3 to 5 years, and to state that the evidence is insufficient to make a recommendation for younger children.⁵

Screening for osteoporosis
The recommendations indicate that all women ages 65 and older should undergo screening, although the optimal frequency of screening is not known. The clinical discussion accompanying the recommendation indicates there is reason to believe that screening men may reduce morbidity and mortality, but that sufficient evidence for or against this is lacking.⁶

Screening can be done with dual-energy x-ray absorptiometry (DEXA) of the hip and lumbar spine, or quantitative ultrasonography of the calcaneus. DEXA is most commonly used, and is the basis for most treatment recommendations.

The recommendation to screen some women younger than 65 years, based on risk, is somewhat complex. The USPSTF recommends screening younger women if their 10-year risk of fracture is comparable to that of a 65-year-old white woman with no additional risk factors (a risk of 9.3% over 10 years). To calculate that risk, the USPSTF recommends using the FRAX (Fracture Risk Assessment) tool developed by the World Health Organization Collaborating Centre for Metabolic Bone Diseases, Sheffield, United Kingdom, which is available free to clinicians and the public (www.shef.ac.uk/FRAX/).

Screening for testicular cancer
The recommendation against screening for testicular cancer may surprise many physicians, even though it is a reaffirmation of a previous recommendation. Testicular cancer is uncommon (5 cases per 100,000 males per year) and treatment is successful in a large proportion of patients, regardless of the stage at which it is discovered. Patients or their partners discover these tumors in time for a cure and there is no evidence physician exams improve outcomes. Physician discovery of incidental and inconsequential findings such as spermatoceles and varicoceles can lead to unnecessary testing and follow-up.⁷

Screening for bladder cancer
The USPSTF issued an I statement for bladder cancer screening because there is little evidence regarding the diagnostic accuracy of available tests (urinalysis for microscopic hematuria, urine cytology, or tests for urine biomarkers) in detecting bladder cancer in asymptomatic patients. In addition, there is no evidence regarding the potential benefits of detecting asymptomatic bladder cancer.⁸

Current draft recommendations

The USPSTF posts recommendations on its Web site for public comment for 30 days. To see current draft recommendations, go to http://www.uspreventiveservicestaskforce.org/tfcomment.htm.

Recently, the US Preventive Services Task Force (USPSTF) finalized 7 recommendations on 5 topics and posted draft recommendations on an additional 10 topics. It also implemented new procedures that include posting draft recommendations for public comment (see “A new review process for the USPSTF”). This article reviews the USPSTF activity in 2011, as well as cervical cancer screening recommendations issued earlier this year.

2012 recommendations

Screening for cervical cancer
The USPSTF released its new recommendations on screening for cervical cancer in March (TABLE 1).¹ The final document varied from the 2011 draft recommendations in 2 areas: the roles of human papillomavirus (HPV) testing and sexual history.

1. The draft issued an I statement (insufficient evidence) for the role of HPV testing. Subsequently, based on stakeholder and public comment (as well as a review of 2 large recently published studies), the USPSTF gave an A recommendation to the use of HPV testing in conjunction with cervical cytology as an option for women ages 30 years and older who want to increase the interval between screening to 5 years.^2,3
2. The draft stated that the age at which screening should be initiated depends on a patient’s sexual history. The final recommendations state that screening should not begin until age 21, regardless of sexual history.

TABLE 1

These new recommendations balance the proven benefits of cervical cytology with the harms from overscreening and are now essentially the same as those of other organizations, including the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology. They differ in minor ways from those of the American Congress of Obstetricians and Gynecologists, and the American Academy of Family Physicians is assessing whether to endorse them.

Importantly, the new recommendations identify individuals for whom cervical cytology should be avoided—women younger than age 21, most women older than age 65, and those who have had a hysterectomy with removal of the cervix. A decision to stop screening after the 65th birthday depends on whether the patient has had adequate screening yielding normal findings: This is defined by the USPSTF as 3 consecutive negative cytology results (or 2 consecutive negative co-test results with cytology and HIV testing) within 10 years of the proposed time of cessation, with the most recent test having been performed within 5 years. Avoiding cytology testing after hysterectomy is contingent on the procedure having been performed for an indication other than a high-grade precancerous lesion or cervical cancer. In addition, the recommendations advise against HPV testing in women younger than age 30, as it offers little advantage and leads to much overdiagnosis.

Liquid vs conventional cytology. As a minor point, the USPSTF says the evidence clearly shows that liquid cytology offers no advantage over conventional cytology. But it recognizes that the screening method used is often not determined by the physician.

Recommendations finalized in 2011

TABLE 2 summarizes recommendations completed by the USPSTF last year.

Neonatal gonococcal eye infection prevention
The recommendation to use topical medication (erythromycin ointment) to prevent neonatal gonococcal eye infection is an update and reaffirmation of a previous recommendation. Blindness due to this disease has become rare in the United States because of the routine use of a neonatal topical antibiotic, and there is good evidence that it causes no significant harm. Its use continues to be recommended for all newborns.⁴

TABLE 2

Vision screening for children
Vision screening for preschool children can detect visual acuity problems such as amblyopia and refractive errors. A variety of screening tests are available, including visual acuity, stereoacuity, cover-uncover, Hirschberg light reflex, and auto-refractor tests (automated optical instruments that detect refractive errors). The most benefit is obtained by discovering and correcting amblyopia.

There is no evidence that detecting problems before age 3 years leads to better outcomes than detection between 3 and 5 years of age. Testing is more difficult in younger children and can yield inconclusive or false-positive results more frequently. This led the USPSTF to reaffirm vision testing once for children ages 3 to 5 years, and to state that the evidence is insufficient to make a recommendation for younger children.⁵

Screening for osteoporosis
The recommendations indicate that all women ages 65 and older should undergo screening, although the optimal frequency of screening is not known. The clinical discussion accompanying the recommendation indicates there is reason to believe that screening men may reduce morbidity and mortality, but that sufficient evidence for or against this is lacking.⁶

Screening can be done with dual-energy x-ray absorptiometry (DEXA) of the hip and lumbar spine, or quantitative ultrasonography of the calcaneus. DEXA is most commonly used, and is the basis for most treatment recommendations.

The recommendation to screen some women younger than 65 years, based on risk, is somewhat complex. The USPSTF recommends screening younger women if their 10-year risk of fracture is comparable to that of a 65-year-old white woman with no additional risk factors (a risk of 9.3% over 10 years). To calculate that risk, the USPSTF recommends using the FRAX (Fracture Risk Assessment) tool developed by the World Health Organization Collaborating Centre for Metabolic Bone Diseases, Sheffield, United Kingdom, which is available free to clinicians and the public (www.shef.ac.uk/FRAX/).

Screening for testicular cancer
The recommendation against screening for testicular cancer may surprise many physicians, even though it is a reaffirmation of a previous recommendation. Testicular cancer is uncommon (5 cases per 100,000 males per year) and treatment is successful in a large proportion of patients, regardless of the stage at which it is discovered. Patients or their partners discover these tumors in time for a cure and there is no evidence physician exams improve outcomes. Physician discovery of incidental and inconsequential findings such as spermatoceles and varicoceles can lead to unnecessary testing and follow-up.⁷

Screening for bladder cancer
The USPSTF issued an I statement for bladder cancer screening because there is little evidence regarding the diagnostic accuracy of available tests (urinalysis for microscopic hematuria, urine cytology, or tests for urine biomarkers) in detecting bladder cancer in asymptomatic patients. In addition, there is no evidence regarding the potential benefits of detecting asymptomatic bladder cancer.⁸

Current draft recommendations

The USPSTF posts recommendations on its Web site for public comment for 30 days. To see current draft recommendations, go to http://www.uspreventiveservicestaskforce.org/tfcomment.htm.

In February, the Centers for Disease Control and Prevention (CDC) published the 2012 immunization schedules for infants and children, adolescents, and adults.^1,2 The schedules, which are available at http://www.cdc.gov/vaccines/recs/schedules/default.htm, are updated annually and incorporate additions and changes recommended by the Advisory Committee on Immunization Practices (ACIP) over the past year. While there were no major advances in new vaccines in 2011, there were a number of new indications for existing ones.

Human papillomavirus vaccine for males
Quadrivalent vaccine against human papillomavirus is now recommended for routine use for males ages 11 to 12 years to prevent genital warts and anal intraepithelial neoplasia.^3,4 Catch-up vaccination is also recommended for males ages 13 to 21 who have not received it. In addition, routine use is recommended for males ages 22 to 26 years who have sex with men or are HIV positive or immuno-compromised.

Tetanus toxoid, reduced strength diphtheria toxoid, and acellular pertussis (Tdap)
Indications for the routine use of Tdap were expanded to include children ages 7 to 10 years, pregnant women, and adults age 65 and older who have contact with infants.^5,6 Children ages 7 to 10 years who have not had the full series of DTaP should receive Td/Tdap according to the catch-up schedule,¹ with one of the doses being Tdap. Adults older than 65 who have never received Tdap and who have close contact with infants should receive one dose. No minimum interval is required between receipt of the Td and Tdap vaccines. Other older adults who ask for Tdap vaccination should receive it. Use of Tdap in those ages 7 to 10 years or 65 and older is off label.⁵

Pregnant women who have not received Tdap should receive 1 dose after week 20 of pregnancy, although receiving it earlier is not contraindicated if tetanus toxoid is needed for tetanus prevention following a wound.⁶

Hepatitis B virus (HBV) vaccine
Added to the list of high-risk adults who should receive HBV vaccine routinely are those ages 19 through 59 years with diabetes.⁷ Vaccinate as soon as possible after the diabetes diagnosis is confirmed. The decision as to whether to vaccinate patients ≥60 years with diabetes should be based on the likelihood that they will become infected. Considerations include the risks associated with an increased need for help with blood-glucose monitoring in long-term care facilities, the likelihood that the patient will experience chronic sequelae if infected, and the likelihood that the patient will mount a proper immune response to the vaccine.⁷ (The more frail patients are, the less likely they are to achieve adequate immunity.⁷)

Meningococcal conjugate vaccine, quadrivalent (MCV4)
An MCV4 vaccine (Menactra) has now been licensed for use in children as young as 9 months.⁸ At this time, however, neither Menactra nor its competitor, Menveo (licensed for use in those 2 years and older), is recommended for routine administration until the age of 11 to 12 years. Infants and children ages 9 through 23 months with complement deficiencies, or who will be traveling to countries with endemic high levels of meningococcus, should be vaccinated with 2 doses of Menactra 3 months apart, and with a booster dose after 3 years if risk persists. The recommendations regarding the use of MCV4 in those ≤2 years with high-risk conditions are listed in TABLE 1.

Another change regarding the use of MCV4 is a recommended booster dose for those age 16 and older who were first vaccinated at age 11 or 12 years.⁹ For those vaccinated at ages 13 to 15, a booster should be received at ages 16 to 18. No booster is needed if the first MCV4 dose is received at or after age 16. Recommendations for MCV4 use and booster doses for those 2 years and older are listed in TABLE 2.

TABLE 1
Recommended Menactra schedule for young children at high risk for invasive meningococcal disease⁸

TABLE 2
Recommended schedule for meningococcal conjugate vaccine in those ≥2 years, according to risk⁹

Herpes zoster vaccine
The herpes zoster vaccine was initially licensed for those 60 years and older. Last year the FDA approved lowering the age to 50 years and older. At this time, however, the ACIP continues to recommend that the vaccine be used routinely starting at age 60 years. The age was not lowered because of a concern about vaccine supply and the uncertainty about the possible need for a booster dose if administered at age 50.¹⁰

Influenza vaccine
As described in a previous Practice Alert,¹¹ a history of egg allergy is no longer a strict contraindication for receipt of the influenza vaccine. The other major adjustment is a simplified recommendation on how to determine the required number of doses for a child younger than 9 years. If the child received 1 or both doses of the 2010-2011 vaccine, give just a single dose of the 2011-2012 vaccine. If the history is uncertain, give 2 doses of the new vaccine at least 4 weeks apart.¹²

In February, the Centers for Disease Control and Prevention (CDC) published the 2012 immunization schedules for infants and children, adolescents, and adults.^1,2 The schedules, which are available at http://www.cdc.gov/vaccines/recs/schedules/default.htm, are updated annually and incorporate additions and changes recommended by the Advisory Committee on Immunization Practices (ACIP) over the past year. While there were no major advances in new vaccines in 2011, there were a number of new indications for existing ones.

Human papillomavirus vaccine for males
Quadrivalent vaccine against human papillomavirus is now recommended for routine use for males ages 11 to 12 years to prevent genital warts and anal intraepithelial neoplasia.^3,4 Catch-up vaccination is also recommended for males ages 13 to 21 who have not received it. In addition, routine use is recommended for males ages 22 to 26 years who have sex with men or are HIV positive or immuno-compromised.

Tetanus toxoid, reduced strength diphtheria toxoid, and acellular pertussis (Tdap)
Indications for the routine use of Tdap were expanded to include children ages 7 to 10 years, pregnant women, and adults age 65 and older who have contact with infants.^5,6 Children ages 7 to 10 years who have not had the full series of DTaP should receive Td/Tdap according to the catch-up schedule,¹ with one of the doses being Tdap. Adults older than 65 who have never received Tdap and who have close contact with infants should receive one dose. No minimum interval is required between receipt of the Td and Tdap vaccines. Other older adults who ask for Tdap vaccination should receive it. Use of Tdap in those ages 7 to 10 years or 65 and older is off label.⁵

Pregnant women who have not received Tdap should receive 1 dose after week 20 of pregnancy, although receiving it earlier is not contraindicated if tetanus toxoid is needed for tetanus prevention following a wound.⁶

Hepatitis B virus (HBV) vaccine
Added to the list of high-risk adults who should receive HBV vaccine routinely are those ages 19 through 59 years with diabetes.⁷ Vaccinate as soon as possible after the diabetes diagnosis is confirmed. The decision as to whether to vaccinate patients ≥60 years with diabetes should be based on the likelihood that they will become infected. Considerations include the risks associated with an increased need for help with blood-glucose monitoring in long-term care facilities, the likelihood that the patient will experience chronic sequelae if infected, and the likelihood that the patient will mount a proper immune response to the vaccine.⁷ (The more frail patients are, the less likely they are to achieve adequate immunity.⁷)

Meningococcal conjugate vaccine, quadrivalent (MCV4)
An MCV4 vaccine (Menactra) has now been licensed for use in children as young as 9 months.⁸ At this time, however, neither Menactra nor its competitor, Menveo (licensed for use in those 2 years and older), is recommended for routine administration until the age of 11 to 12 years. Infants and children ages 9 through 23 months with complement deficiencies, or who will be traveling to countries with endemic high levels of meningococcus, should be vaccinated with 2 doses of Menactra 3 months apart, and with a booster dose after 3 years if risk persists. The recommendations regarding the use of MCV4 in those ≤2 years with high-risk conditions are listed in TABLE 1.

Another change regarding the use of MCV4 is a recommended booster dose for those age 16 and older who were first vaccinated at age 11 or 12 years.⁹ For those vaccinated at ages 13 to 15, a booster should be received at ages 16 to 18. No booster is needed if the first MCV4 dose is received at or after age 16. Recommendations for MCV4 use and booster doses for those 2 years and older are listed in TABLE 2.

TABLE 1
Recommended Menactra schedule for young children at high risk for invasive meningococcal disease⁸

TABLE 2
Recommended schedule for meningococcal conjugate vaccine in those ≥2 years, according to risk⁹

Herpes zoster vaccine
The herpes zoster vaccine was initially licensed for those 60 years and older. Last year the FDA approved lowering the age to 50 years and older. At this time, however, the ACIP continues to recommend that the vaccine be used routinely starting at age 60 years. The age was not lowered because of a concern about vaccine supply and the uncertainty about the possible need for a booster dose if administered at age 50.¹⁰

Influenza vaccine
As described in a previous Practice Alert,¹¹ a history of egg allergy is no longer a strict contraindication for receipt of the influenza vaccine. The other major adjustment is a simplified recommendation on how to determine the required number of doses for a child younger than 9 years. If the child received 1 or both doses of the 2010-2011 vaccine, give just a single dose of the 2011-2012 vaccine. If the history is uncertain, give 2 doses of the new vaccine at least 4 weeks apart.¹²

In February, the Centers for Disease Control and Prevention (CDC) published the 2012 immunization schedules for infants and children, adolescents, and adults.^1,2 The schedules, which are available at http://www.cdc.gov/vaccines/recs/schedules/default.htm, are updated annually and incorporate additions and changes recommended by the Advisory Committee on Immunization Practices (ACIP) over the past year. While there were no major advances in new vaccines in 2011, there were a number of new indications for existing ones.

Human papillomavirus vaccine for males
Quadrivalent vaccine against human papillomavirus is now recommended for routine use for males ages 11 to 12 years to prevent genital warts and anal intraepithelial neoplasia.^3,4 Catch-up vaccination is also recommended for males ages 13 to 21 who have not received it. In addition, routine use is recommended for males ages 22 to 26 years who have sex with men or are HIV positive or immuno-compromised.

Tetanus toxoid, reduced strength diphtheria toxoid, and acellular pertussis (Tdap)
Indications for the routine use of Tdap were expanded to include children ages 7 to 10 years, pregnant women, and adults age 65 and older who have contact with infants.^5,6 Children ages 7 to 10 years who have not had the full series of DTaP should receive Td/Tdap according to the catch-up schedule,¹ with one of the doses being Tdap. Adults older than 65 who have never received Tdap and who have close contact with infants should receive one dose. No minimum interval is required between receipt of the Td and Tdap vaccines. Other older adults who ask for Tdap vaccination should receive it. Use of Tdap in those ages 7 to 10 years or 65 and older is off label.⁵

Pregnant women who have not received Tdap should receive 1 dose after week 20 of pregnancy, although receiving it earlier is not contraindicated if tetanus toxoid is needed for tetanus prevention following a wound.⁶

Hepatitis B virus (HBV) vaccine
Added to the list of high-risk adults who should receive HBV vaccine routinely are those ages 19 through 59 years with diabetes.⁷ Vaccinate as soon as possible after the diabetes diagnosis is confirmed. The decision as to whether to vaccinate patients ≥60 years with diabetes should be based on the likelihood that they will become infected. Considerations include the risks associated with an increased need for help with blood-glucose monitoring in long-term care facilities, the likelihood that the patient will experience chronic sequelae if infected, and the likelihood that the patient will mount a proper immune response to the vaccine.⁷ (The more frail patients are, the less likely they are to achieve adequate immunity.⁷)

Meningococcal conjugate vaccine, quadrivalent (MCV4)
An MCV4 vaccine (Menactra) has now been licensed for use in children as young as 9 months.⁸ At this time, however, neither Menactra nor its competitor, Menveo (licensed for use in those 2 years and older), is recommended for routine administration until the age of 11 to 12 years. Infants and children ages 9 through 23 months with complement deficiencies, or who will be traveling to countries with endemic high levels of meningococcus, should be vaccinated with 2 doses of Menactra 3 months apart, and with a booster dose after 3 years if risk persists. The recommendations regarding the use of MCV4 in those ≤2 years with high-risk conditions are listed in TABLE 1.

Another change regarding the use of MCV4 is a recommended booster dose for those age 16 and older who were first vaccinated at age 11 or 12 years.⁹ For those vaccinated at ages 13 to 15, a booster should be received at ages 16 to 18. No booster is needed if the first MCV4 dose is received at or after age 16. Recommendations for MCV4 use and booster doses for those 2 years and older are listed in TABLE 2.

TABLE 1
Recommended Menactra schedule for young children at high risk for invasive meningococcal disease⁸

TABLE 2
Recommended schedule for meningococcal conjugate vaccine in those ≥2 years, according to risk⁹

Herpes zoster vaccine
The herpes zoster vaccine was initially licensed for those 60 years and older. Last year the FDA approved lowering the age to 50 years and older. At this time, however, the ACIP continues to recommend that the vaccine be used routinely starting at age 60 years. The age was not lowered because of a concern about vaccine supply and the uncertainty about the possible need for a booster dose if administered at age 50.¹⁰

Influenza vaccine
As described in a previous Practice Alert,¹¹ a history of egg allergy is no longer a strict contraindication for receipt of the influenza vaccine. The other major adjustment is a simplified recommendation on how to determine the required number of doses for a child younger than 9 years. If the child received 1 or both doses of the 2010-2011 vaccine, give just a single dose of the 2011-2012 vaccine. If the history is uncertain, give 2 doses of the new vaccine at least 4 weeks apart.¹²

At its October 2011 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended to the CDC that quadrivalent human papilloma virus vaccine (HPV4, Gardasil) be routinely given to all males ages 11 to 21 and to men ages 22 to 26 who have sex with men or who are HIV positive, if they have not been previously vaccinated. This replaces a 2009 recommendation that stated HPV4 vaccine could be used in males to prevent genital warts, but stopped short of advocating routine use for all males.¹

There were 3 reasons the previous recommendation did not include HPV4 for routine vaccination of males:

1. The vaccine had been shown to be effective only for prevention of genital warts.
2. The cost effectiveness of the vaccine for use in boys was poor and, in modeling, it yielded less benefit as more females were vaccinated.
3. It was thought that a more effective approach to preventing HPV disease would be to emphasize high rates of vaccination of females.

The new recommendation takes into account recent evidence demonstrating that the vaccine prevents anal intraepithelial neoplasia (AIN) in males, in addition to genital warts. Moreover, vaccination rates in females remain low, which makes vaccinating males more cost effective and additionally protective for females.

Female vaccination rates lower than expected

Despite its effectiveness and safety record, HPV vaccination has had a slow rate of acceptance among females ages 13 to 17 years. Coverage for this group documented in the last national vaccine survey was 48.7% for one dose and 32% for the recommended 3 doses.²

The vaccine is effective in preventing cervical intraepithelial neoplasia (TABLE 1),³ condyloma, and vaginal intraepithelial neoplasia in women ~15 to 26 years of age. Large studies of vaccine safety have documented no serious adverse reactions, other than syncope, which could occur as frequently as 17.9/10,000 females and 12.5/10,000 males.⁴ Another study that involved post-licensure safety data from >600,000 HPV4 doses found no increased risk for a variety of outcomes, including Guillain-Barré syndrome, stroke, venous thromboembolism, appendicitis, seizures, syncope, allergic reactions, and anaphylaxis.^5,6

TABLE 1
HPV vaccine efficacy against HPV type-related CIN2+ in females ages ~15 to 26 years³

HPV-associated disease in males

HPV causes anal, penile, and oropharyngeal cancers in males, with about 7500 cancers occurring each year in the United States.³ In addition, about 1% of sexually active males in America have genital warts at any one time.⁷ HPV types 6 and 11 cause about 90% of cases.¹

The HPV4 vaccine—when all 3 doses are given—is 89.3% effective in preventing genital warts related to HPV types 6 and 11. Even a single dose is 68.1% effective (95% CI, 48.8–80.7).¹ New evidence shows that HPV4 prevents AIN, which can lead to anal cancer.⁸ Effectiveness in preventing AIN 2/3 is 74.9% (95% CI, 8.8–95.4) in those completing 3 doses before onset of infection with one of the HPV types contained in vaccine. Notably, these results were obtained in a subgroup analysis of men who have sex with men. And although the reduction in AIN is expected to lower the incidence of anal cancer, ongoing studies require time to confirm this. If such a reduction is confirmed (and vaccination is started at age 12 in the general male population), the number-needed-to-vaccinate to prevent one case of genital warts would be 18, and to prevent one case of anal cancer, 1581.⁶

No studies have evaluated efficacy of HPV4 in preventing penile or oropharyngeal cancers.

Men who have sex with men at high risk
Men who have sex with men have higher rates of AIN, anal cancers, and genital warts than the general male population.³ Those who are additionally HIV positive have higher rates of genital warts, which are also more difficult to treat.³ AIN is also more common in HIV-infected males.³ The HPV4 vaccine is immunogenic in those who are HIV infected, although the resulting antibody titers are lower than in other populations.

A look at the 2 HPV vaccines
Two HPV vaccines are available (TABLE 2).³ HPV4 vaccine protects against HPV 6, 11, 16, and 18. Bivalent (HPV2, Cervarix) vaccine contains antigens from HPV 16 and 18. Both vaccines are approved for use in females for the prevention of cervical cancer; HPV4 is preferred if protection against genital warts is also desired. Only HPV4 has been licensed for use in males.

TABLE 2
A look at the human papillomavirus vaccines³

HPV vaccine is effective, but costly

A major consideration with HPV vaccines is their cost. With 3 doses required and each dose costing about $130,⁹ cost effectiveness is poor when preventing uncommon diseases such as cervical and anal cancer, and a relatively benign disease such as genital warts. Male vaccination at age 12 years, when added to a female vaccination program, costs about $20,000 to $40,000 per quality-adjusted life year (QALY) if all potential HPV morbidity is included, not just that which has been proven to be prevented by the vaccine (assuming oral and penile cancer will also be prevented). Counting only HPV disease demonstrated to be prevented by the vaccine, the result is $75,000 to $250,000+ per QALY.⁶ Vaccinating males older than 21 years results in a cost per QALY 2 to 4 times that of vaccinating males younger than 18 years.¹⁰

A final decision. After considering these factors, ACIP approved a set of recommendations at its October 2011 meeting that will become official once they are published in the Morbidity and Mortality Weekly Report. (See “ACIP recommendations for HPV vaccine use in males”.)

At its October 2011 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended to the CDC that quadrivalent human papilloma virus vaccine (HPV4, Gardasil) be routinely given to all males ages 11 to 21 and to men ages 22 to 26 who have sex with men or who are HIV positive, if they have not been previously vaccinated. This replaces a 2009 recommendation that stated HPV4 vaccine could be used in males to prevent genital warts, but stopped short of advocating routine use for all males.¹

There were 3 reasons the previous recommendation did not include HPV4 for routine vaccination of males:

1. The vaccine had been shown to be effective only for prevention of genital warts.
2. The cost effectiveness of the vaccine for use in boys was poor and, in modeling, it yielded less benefit as more females were vaccinated.
3. It was thought that a more effective approach to preventing HPV disease would be to emphasize high rates of vaccination of females.

The new recommendation takes into account recent evidence demonstrating that the vaccine prevents anal intraepithelial neoplasia (AIN) in males, in addition to genital warts. Moreover, vaccination rates in females remain low, which makes vaccinating males more cost effective and additionally protective for females.

Female vaccination rates lower than expected

Despite its effectiveness and safety record, HPV vaccination has had a slow rate of acceptance among females ages 13 to 17 years. Coverage for this group documented in the last national vaccine survey was 48.7% for one dose and 32% for the recommended 3 doses.²

The vaccine is effective in preventing cervical intraepithelial neoplasia (TABLE 1),³ condyloma, and vaginal intraepithelial neoplasia in women ~15 to 26 years of age. Large studies of vaccine safety have documented no serious adverse reactions, other than syncope, which could occur as frequently as 17.9/10,000 females and 12.5/10,000 males.⁴ Another study that involved post-licensure safety data from >600,000 HPV4 doses found no increased risk for a variety of outcomes, including Guillain-Barré syndrome, stroke, venous thromboembolism, appendicitis, seizures, syncope, allergic reactions, and anaphylaxis.^5,6

TABLE 1
HPV vaccine efficacy against HPV type-related CIN2+ in females ages ~15 to 26 years³

HPV-associated disease in males

HPV causes anal, penile, and oropharyngeal cancers in males, with about 7500 cancers occurring each year in the United States.³ In addition, about 1% of sexually active males in America have genital warts at any one time.⁷ HPV types 6 and 11 cause about 90% of cases.¹

The HPV4 vaccine—when all 3 doses are given—is 89.3% effective in preventing genital warts related to HPV types 6 and 11. Even a single dose is 68.1% effective (95% CI, 48.8–80.7).¹ New evidence shows that HPV4 prevents AIN, which can lead to anal cancer.⁸ Effectiveness in preventing AIN 2/3 is 74.9% (95% CI, 8.8–95.4) in those completing 3 doses before onset of infection with one of the HPV types contained in vaccine. Notably, these results were obtained in a subgroup analysis of men who have sex with men. And although the reduction in AIN is expected to lower the incidence of anal cancer, ongoing studies require time to confirm this. If such a reduction is confirmed (and vaccination is started at age 12 in the general male population), the number-needed-to-vaccinate to prevent one case of genital warts would be 18, and to prevent one case of anal cancer, 1581.⁶

No studies have evaluated efficacy of HPV4 in preventing penile or oropharyngeal cancers.

Men who have sex with men at high risk
Men who have sex with men have higher rates of AIN, anal cancers, and genital warts than the general male population.³ Those who are additionally HIV positive have higher rates of genital warts, which are also more difficult to treat.³ AIN is also more common in HIV-infected males.³ The HPV4 vaccine is immunogenic in those who are HIV infected, although the resulting antibody titers are lower than in other populations.

A look at the 2 HPV vaccines
Two HPV vaccines are available (TABLE 2).³ HPV4 vaccine protects against HPV 6, 11, 16, and 18. Bivalent (HPV2, Cervarix) vaccine contains antigens from HPV 16 and 18. Both vaccines are approved for use in females for the prevention of cervical cancer; HPV4 is preferred if protection against genital warts is also desired. Only HPV4 has been licensed for use in males.

TABLE 2
A look at the human papillomavirus vaccines³

HPV vaccine is effective, but costly

A major consideration with HPV vaccines is their cost. With 3 doses required and each dose costing about $130,⁹ cost effectiveness is poor when preventing uncommon diseases such as cervical and anal cancer, and a relatively benign disease such as genital warts. Male vaccination at age 12 years, when added to a female vaccination program, costs about $20,000 to $40,000 per quality-adjusted life year (QALY) if all potential HPV morbidity is included, not just that which has been proven to be prevented by the vaccine (assuming oral and penile cancer will also be prevented). Counting only HPV disease demonstrated to be prevented by the vaccine, the result is $75,000 to $250,000+ per QALY.⁶ Vaccinating males older than 21 years results in a cost per QALY 2 to 4 times that of vaccinating males younger than 18 years.¹⁰

A final decision. After considering these factors, ACIP approved a set of recommendations at its October 2011 meeting that will become official once they are published in the Morbidity and Mortality Weekly Report. (See “ACIP recommendations for HPV vaccine use in males”.)

At its October 2011 meeting, the Advisory Committee on Immunization Practices (ACIP) recommended to the CDC that quadrivalent human papilloma virus vaccine (HPV4, Gardasil) be routinely given to all males ages 11 to 21 and to men ages 22 to 26 who have sex with men or who are HIV positive, if they have not been previously vaccinated. This replaces a 2009 recommendation that stated HPV4 vaccine could be used in males to prevent genital warts, but stopped short of advocating routine use for all males.¹

There were 3 reasons the previous recommendation did not include HPV4 for routine vaccination of males:

1. The vaccine had been shown to be effective only for prevention of genital warts.
2. The cost effectiveness of the vaccine for use in boys was poor and, in modeling, it yielded less benefit as more females were vaccinated.
3. It was thought that a more effective approach to preventing HPV disease would be to emphasize high rates of vaccination of females.

The new recommendation takes into account recent evidence demonstrating that the vaccine prevents anal intraepithelial neoplasia (AIN) in males, in addition to genital warts. Moreover, vaccination rates in females remain low, which makes vaccinating males more cost effective and additionally protective for females.

Female vaccination rates lower than expected

Despite its effectiveness and safety record, HPV vaccination has had a slow rate of acceptance among females ages 13 to 17 years. Coverage for this group documented in the last national vaccine survey was 48.7% for one dose and 32% for the recommended 3 doses.²

The vaccine is effective in preventing cervical intraepithelial neoplasia (TABLE 1),³ condyloma, and vaginal intraepithelial neoplasia in women ~15 to 26 years of age. Large studies of vaccine safety have documented no serious adverse reactions, other than syncope, which could occur as frequently as 17.9/10,000 females and 12.5/10,000 males.⁴ Another study that involved post-licensure safety data from >600,000 HPV4 doses found no increased risk for a variety of outcomes, including Guillain-Barré syndrome, stroke, venous thromboembolism, appendicitis, seizures, syncope, allergic reactions, and anaphylaxis.^5,6

TABLE 1
HPV vaccine efficacy against HPV type-related CIN2+ in females ages ~15 to 26 years³

HPV-associated disease in males

HPV causes anal, penile, and oropharyngeal cancers in males, with about 7500 cancers occurring each year in the United States.³ In addition, about 1% of sexually active males in America have genital warts at any one time.⁷ HPV types 6 and 11 cause about 90% of cases.¹

The HPV4 vaccine—when all 3 doses are given—is 89.3% effective in preventing genital warts related to HPV types 6 and 11. Even a single dose is 68.1% effective (95% CI, 48.8–80.7).¹ New evidence shows that HPV4 prevents AIN, which can lead to anal cancer.⁸ Effectiveness in preventing AIN 2/3 is 74.9% (95% CI, 8.8–95.4) in those completing 3 doses before onset of infection with one of the HPV types contained in vaccine. Notably, these results were obtained in a subgroup analysis of men who have sex with men. And although the reduction in AIN is expected to lower the incidence of anal cancer, ongoing studies require time to confirm this. If such a reduction is confirmed (and vaccination is started at age 12 in the general male population), the number-needed-to-vaccinate to prevent one case of genital warts would be 18, and to prevent one case of anal cancer, 1581.⁶

No studies have evaluated efficacy of HPV4 in preventing penile or oropharyngeal cancers.

Men who have sex with men at high risk
Men who have sex with men have higher rates of AIN, anal cancers, and genital warts than the general male population.³ Those who are additionally HIV positive have higher rates of genital warts, which are also more difficult to treat.³ AIN is also more common in HIV-infected males.³ The HPV4 vaccine is immunogenic in those who are HIV infected, although the resulting antibody titers are lower than in other populations.

A look at the 2 HPV vaccines
Two HPV vaccines are available (TABLE 2).³ HPV4 vaccine protects against HPV 6, 11, 16, and 18. Bivalent (HPV2, Cervarix) vaccine contains antigens from HPV 16 and 18. Both vaccines are approved for use in females for the prevention of cervical cancer; HPV4 is preferred if protection against genital warts is also desired. Only HPV4 has been licensed for use in males.

TABLE 2
A look at the human papillomavirus vaccines³

HPV vaccine is effective, but costly

A major consideration with HPV vaccines is their cost. With 3 doses required and each dose costing about $130,⁹ cost effectiveness is poor when preventing uncommon diseases such as cervical and anal cancer, and a relatively benign disease such as genital warts. Male vaccination at age 12 years, when added to a female vaccination program, costs about $20,000 to $40,000 per quality-adjusted life year (QALY) if all potential HPV morbidity is included, not just that which has been proven to be prevented by the vaccine (assuming oral and penile cancer will also be prevented). Counting only HPV disease demonstrated to be prevented by the vaccine, the result is $75,000 to $250,000+ per QALY.⁶ Vaccinating males older than 21 years results in a cost per QALY 2 to 4 times that of vaccinating males younger than 18 years.¹⁰

A final decision. After considering these factors, ACIP approved a set of recommendations at its October 2011 meeting that will become official once they are published in the Morbidity and Mortality Weekly Report. (See “ACIP recommendations for HPV vaccine use in males”.)

Public health efforts have decreased the incidence of gonorrhea over the past several decades, but this progress is threatened by emergent bacteria resistance to the few remaining antibiotics available to treat it.

Gonococcal resistance to penicillin and tetracycline began in the 1970s and was widespread by the 1980s. Resistance to fluoroquinolones developed during the last decade and led the Centers for Disease Control and Prevention (CDC) in 2007 to stop recommending this class of antibiotics for treatment of gonorrhea.¹ (See “The decline of gonorrhea: A success story now threatened by antibiotic resistance”.)

Given the speed with which gonococci developed resistance to fluoroquinolones, the CDC sees as inevitable the eventual development of resistance to cephalosporins—the currently favored agents for gonorrhea.² This is the main reason behind the new recommendations for treating all cases of gonorrhea with both a cephalosporin and azithromycin, whether or not co-infection with Chlamydia trachomatis is documented or suspected.³

FIGURE 1
A decline in gonorrhea that began in the mid-1970s*

FIGURE 2
Gonorrhea prevalence, 2010

FIGURE 3
Gonorrhea prevalence by age and sex, 2010

Augment therapy, follow up thoroughly

Family physicians can assist with public health efforts to control gonorrhea and delay the development of cephalosporin resistance by screening for and detecting the infection, diagnosing those with symptoms, and treating according to newer recommendations. It’s also essential to report cases to local public health departments, assist with finding and treating sexual contacts of infected individuals, and immediately report suspected treatment failures.

A 2-drug regimen is imperative. The latest recommendation for treating gonorrhea is ceftriaxone 250 mg IM in a single dose and azithromycin 1 g orally in a single dose. Until 2010, the dose of ceftriaxone had been 125 mg. This dual drug regimen is recommended for several reasons: As with using multiple drugs to treat tuberculosis, it is hoped dual drug therapy will slow development of resistance to both cephalosporins and azithromycin; co-infection with C trachomatis remains a significant problem; and the combination may be more effective against pharyngeal gonorrhea, which is hard to detect.

Alternative regimens. Cefixime 400 mg orally as a single dose is an option in lieu of ceftriaxone, but is not preferred because of the higher number of reported failures of treatment with oral cephalosporins and less efficacy against pharyngeal disease.³ Other injectable cephalosporins are also an option, but less is known about their effectiveness in treating pharyngeal infection. Injectable options include ceftizoxime 500 mg IM, cefoxitin 2 g IM with probenecid 1 g orally, and cefotaxime 500 mg IM.

Regardless of the cephalosporin chosen, always administer azithromycin. If necessary, an alternative to azithromycin is doxycycline 100 mg orally twice a day. But doxycycline is not preferred because it has a multiple daily dosing requirement and higher levels of gonococcal resistance than is seen with azithromycin.

Necessary follow-up. Although routine testing for cure is not advocated for those treated with a recommended antibiotic regimen, a gonococcal culture and testing for antibiotic susceptibility should be done for any patient whose symptoms persist after treatment. Rapid tests using nucleic acid amplification are unsuitable for testing antibiotic susceptibility. The CDC does recommend retesting patients 3 months after treatment is completed because of a high prevalence of reinfection.³ If cephalosporin resistance becomes prevalent, routine tests of cure might become a recommended standard.

Report all patients with gonorrhea to the local public health department so that sexual contacts within the past 60 days can be notified, tested, and treated presumptively with the dual drug regimen. Recommend simultaneous treatment for all current sex partners, and discourage sexual intercourse until symptoms have resolved. Promptly report any patient with suspected treatment failure to the local health department, and consult the local or state health department for recommendations on subsequent treatment regimens.

The US Preventive Services Task Force (USPSTF) recommends routine screening for asymptomatic infection in women at risk, as per the details in the TABLE.⁴ While the USPSTF found insufficient evidence to recommend screening of high-risk men, physicians might still consider screening men who have sex with multiple male partners.

TABLE
USPSTF recommendations on screening for gonorrhea⁴

Doing our best in the face of uncertainty
Although evidence is lacking that dual drug therapy will delay the progression of resistance, the strategy makes empirical sense. If gonorrhea develops resistance to cephalosporins, it will seriously challenge public health efforts to control this infection. Family physicians have an important role in controlling this sexually transmitted infection and helping to prevent drug resistance.

Public health efforts have decreased the incidence of gonorrhea over the past several decades, but this progress is threatened by emergent bacteria resistance to the few remaining antibiotics available to treat it.

Gonococcal resistance to penicillin and tetracycline began in the 1970s and was widespread by the 1980s. Resistance to fluoroquinolones developed during the last decade and led the Centers for Disease Control and Prevention (CDC) in 2007 to stop recommending this class of antibiotics for treatment of gonorrhea.¹ (See “The decline of gonorrhea: A success story now threatened by antibiotic resistance”.)

Given the speed with which gonococci developed resistance to fluoroquinolones, the CDC sees as inevitable the eventual development of resistance to cephalosporins—the currently favored agents for gonorrhea.² This is the main reason behind the new recommendations for treating all cases of gonorrhea with both a cephalosporin and azithromycin, whether or not co-infection with Chlamydia trachomatis is documented or suspected.³

FIGURE 1
A decline in gonorrhea that began in the mid-1970s*

FIGURE 2
Gonorrhea prevalence, 2010

FIGURE 3
Gonorrhea prevalence by age and sex, 2010

Augment therapy, follow up thoroughly

Family physicians can assist with public health efforts to control gonorrhea and delay the development of cephalosporin resistance by screening for and detecting the infection, diagnosing those with symptoms, and treating according to newer recommendations. It’s also essential to report cases to local public health departments, assist with finding and treating sexual contacts of infected individuals, and immediately report suspected treatment failures.

A 2-drug regimen is imperative. The latest recommendation for treating gonorrhea is ceftriaxone 250 mg IM in a single dose and azithromycin 1 g orally in a single dose. Until 2010, the dose of ceftriaxone had been 125 mg. This dual drug regimen is recommended for several reasons: As with using multiple drugs to treat tuberculosis, it is hoped dual drug therapy will slow development of resistance to both cephalosporins and azithromycin; co-infection with C trachomatis remains a significant problem; and the combination may be more effective against pharyngeal gonorrhea, which is hard to detect.

Alternative regimens. Cefixime 400 mg orally as a single dose is an option in lieu of ceftriaxone, but is not preferred because of the higher number of reported failures of treatment with oral cephalosporins and less efficacy against pharyngeal disease.³ Other injectable cephalosporins are also an option, but less is known about their effectiveness in treating pharyngeal infection. Injectable options include ceftizoxime 500 mg IM, cefoxitin 2 g IM with probenecid 1 g orally, and cefotaxime 500 mg IM.

Regardless of the cephalosporin chosen, always administer azithromycin. If necessary, an alternative to azithromycin is doxycycline 100 mg orally twice a day. But doxycycline is not preferred because it has a multiple daily dosing requirement and higher levels of gonococcal resistance than is seen with azithromycin.

Necessary follow-up. Although routine testing for cure is not advocated for those treated with a recommended antibiotic regimen, a gonococcal culture and testing for antibiotic susceptibility should be done for any patient whose symptoms persist after treatment. Rapid tests using nucleic acid amplification are unsuitable for testing antibiotic susceptibility. The CDC does recommend retesting patients 3 months after treatment is completed because of a high prevalence of reinfection.³ If cephalosporin resistance becomes prevalent, routine tests of cure might become a recommended standard.

Report all patients with gonorrhea to the local public health department so that sexual contacts within the past 60 days can be notified, tested, and treated presumptively with the dual drug regimen. Recommend simultaneous treatment for all current sex partners, and discourage sexual intercourse until symptoms have resolved. Promptly report any patient with suspected treatment failure to the local health department, and consult the local or state health department for recommendations on subsequent treatment regimens.

The US Preventive Services Task Force (USPSTF) recommends routine screening for asymptomatic infection in women at risk, as per the details in the TABLE.⁴ While the USPSTF found insufficient evidence to recommend screening of high-risk men, physicians might still consider screening men who have sex with multiple male partners.

TABLE
USPSTF recommendations on screening for gonorrhea⁴

Doing our best in the face of uncertainty
Although evidence is lacking that dual drug therapy will delay the progression of resistance, the strategy makes empirical sense. If gonorrhea develops resistance to cephalosporins, it will seriously challenge public health efforts to control this infection. Family physicians have an important role in controlling this sexually transmitted infection and helping to prevent drug resistance.

Public health efforts have decreased the incidence of gonorrhea over the past several decades, but this progress is threatened by emergent bacteria resistance to the few remaining antibiotics available to treat it.

Gonococcal resistance to penicillin and tetracycline began in the 1970s and was widespread by the 1980s. Resistance to fluoroquinolones developed during the last decade and led the Centers for Disease Control and Prevention (CDC) in 2007 to stop recommending this class of antibiotics for treatment of gonorrhea.¹ (See “The decline of gonorrhea: A success story now threatened by antibiotic resistance”.)

Given the speed with which gonococci developed resistance to fluoroquinolones, the CDC sees as inevitable the eventual development of resistance to cephalosporins—the currently favored agents for gonorrhea.² This is the main reason behind the new recommendations for treating all cases of gonorrhea with both a cephalosporin and azithromycin, whether or not co-infection with Chlamydia trachomatis is documented or suspected.³

FIGURE 1
A decline in gonorrhea that began in the mid-1970s*

FIGURE 2
Gonorrhea prevalence, 2010

FIGURE 3
Gonorrhea prevalence by age and sex, 2010

Augment therapy, follow up thoroughly

Family physicians can assist with public health efforts to control gonorrhea and delay the development of cephalosporin resistance by screening for and detecting the infection, diagnosing those with symptoms, and treating according to newer recommendations. It’s also essential to report cases to local public health departments, assist with finding and treating sexual contacts of infected individuals, and immediately report suspected treatment failures.

A 2-drug regimen is imperative. The latest recommendation for treating gonorrhea is ceftriaxone 250 mg IM in a single dose and azithromycin 1 g orally in a single dose. Until 2010, the dose of ceftriaxone had been 125 mg. This dual drug regimen is recommended for several reasons: As with using multiple drugs to treat tuberculosis, it is hoped dual drug therapy will slow development of resistance to both cephalosporins and azithromycin; co-infection with C trachomatis remains a significant problem; and the combination may be more effective against pharyngeal gonorrhea, which is hard to detect.

Alternative regimens. Cefixime 400 mg orally as a single dose is an option in lieu of ceftriaxone, but is not preferred because of the higher number of reported failures of treatment with oral cephalosporins and less efficacy against pharyngeal disease.³ Other injectable cephalosporins are also an option, but less is known about their effectiveness in treating pharyngeal infection. Injectable options include ceftizoxime 500 mg IM, cefoxitin 2 g IM with probenecid 1 g orally, and cefotaxime 500 mg IM.

Regardless of the cephalosporin chosen, always administer azithromycin. If necessary, an alternative to azithromycin is doxycycline 100 mg orally twice a day. But doxycycline is not preferred because it has a multiple daily dosing requirement and higher levels of gonococcal resistance than is seen with azithromycin.

Necessary follow-up. Although routine testing for cure is not advocated for those treated with a recommended antibiotic regimen, a gonococcal culture and testing for antibiotic susceptibility should be done for any patient whose symptoms persist after treatment. Rapid tests using nucleic acid amplification are unsuitable for testing antibiotic susceptibility. The CDC does recommend retesting patients 3 months after treatment is completed because of a high prevalence of reinfection.³ If cephalosporin resistance becomes prevalent, routine tests of cure might become a recommended standard.

Report all patients with gonorrhea to the local public health department so that sexual contacts within the past 60 days can be notified, tested, and treated presumptively with the dual drug regimen. Recommend simultaneous treatment for all current sex partners, and discourage sexual intercourse until symptoms have resolved. Promptly report any patient with suspected treatment failure to the local health department, and consult the local or state health department for recommendations on subsequent treatment regimens.

The US Preventive Services Task Force (USPSTF) recommends routine screening for asymptomatic infection in women at risk, as per the details in the TABLE.⁴ While the USPSTF found insufficient evidence to recommend screening of high-risk men, physicians might still consider screening men who have sex with multiple male partners.

TABLE
USPSTF recommendations on screening for gonorrhea⁴

Doing our best in the face of uncertainty
Although evidence is lacking that dual drug therapy will delay the progression of resistance, the strategy makes empirical sense. If gonorrhea develops resistance to cephalosporins, it will seriously challenge public health efforts to control this infection. Family physicians have an important role in controlling this sexually transmitted infection and helping to prevent drug resistance.

The Centers for Disease Control and Prevention (CDC) has released recommendations made by the Advisory Committee for Immunization Practices (ACIP) for using influenza vaccine for the upcoming influenza season.¹ The recommendations, which are easier to follow than in past years, continue to advise that patients older than 6 months of age (without a contraindication) be vaccinated annually. But there are some newer recommendations, as well, and they are reviewed here.

2011-2012 vaccine choices include a new product

Although the virus strains in the 2011-2012 vaccines are the same as in 2010-2011²—A/California/7/2009 (H1N1)-like, A/Perth/16/ 2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens—individuals vaccinated last year should receive the vaccine again this year. Over the course of a year, antibodies that developed in response to an influenza vaccine decline, and it is believed that even if the vaccine strains have not changed, annual vaccination confers optimal protection.

Although all influenza vaccine products available in the United States contain the same virus strains, the products contain either killed virus (trivalent influenza vaccine [TIV]) or live virus (live attenuated influenza vaccine [LAIV]). The only LAIV vaccine available is the intranasally administered FluMist (MedImmune). It is licensed for use in those between the ages of 2 and 49 years who are healthy, nonpregnant, and without high-risk medical conditions. The CDC does not state a preference for LAIV or TIV in this age group.

A new intradermally administered TIV, Fluzone Intradermal (Sanofi Pasteur),³ was licensed in May 2011 for use in individuals ages 18 through 64 years. It contains less antigen than intramuscular TIV options and is administered in a smaller volume (0.1 rather than 0.5 mL). The preferred site of administration is over the deltoid muscle. Injection-site erythema, induration, swelling, and pruritus occur more frequently than with intramuscular vaccine, but usually these reactions are self-limited, resolving within 3 to 7 days.

Again this coming season, a higher antigen product, Fluzone High-Dose (Sanofi Pasteur), will be available for adults ages 65 and older.⁴ Fluzone High-Dose contains 4 times the amount of influenza antigen as other TIV options. Ongoing studies are comparing this product with others for effectiveness and rates of adverse reactions. At this time, however, ACIP has not identified a preferred TIV product for this age group.

Easier decision making with young children
How to determine the number of doses needed by a child younger than 9 years has been simplified. If the child received 1 or more doses of vaccine last season, only 1 dose is needed this year. If no vaccine was received last year or if that status is unknown, 2 doses are recommended (FIGURE).¹

FIGURE
How many doses of flu vaccine for children 6 months through 8 years of age?¹

Egg allergy does not necessarily prohibit vaccination
The last recommendation change this season is that a history of egg allergy is no longer an automatic contraindication to influenza vaccine.¹ The only contraindication to receiving the vaccine is a prior severe allergic reaction to influenza vaccine. ACIP now states that individuals who have experienced only hives after exposure to egg should receive the vaccine, but only a TIV product and only from a health care provider who is familiar with the potential manifestations of egg allergy. Additionally, those who receive the vaccine should be observed for at least 30 minutes for signs of a reaction.

In the past, some providers have used a 2-step approach (giving a small proportion as a dose first; then, if no reaction occurs, administering the remaining portion). Others have recommended skin testing with vaccine before administration. Neither of these approaches is necessary, according to ACIP, which cites studies that showed skin prick testing with vaccine is poorly predictive of allergic reactions and administration of both full doses and 2-step doses have been well tolerated.¹

Many people reporting egg allergy will not have a reaction to influenza vaccine.¹ In addition, current influenza vaccine products contain very low levels of egg protein. Individuals more likely to have a serious reaction are those who have had severe reactions to egg—eg, angioedema, respiratory distress, light-headedness, or recurrent emesis, or who required epinephrine or other emergency medical interventions. Such people should be referred to a physician with expertise in the management of allergic conditions for further risk assessment.¹ As another precaution, the ACIP recommendations state that all vaccines should be administered in settings where equipment is on hand for treatment of anaphylaxis and where providers are trained in the recognition and treatment of allergic reactions.

The Centers for Disease Control and Prevention (CDC) has released recommendations made by the Advisory Committee for Immunization Practices (ACIP) for using influenza vaccine for the upcoming influenza season.¹ The recommendations, which are easier to follow than in past years, continue to advise that patients older than 6 months of age (without a contraindication) be vaccinated annually. But there are some newer recommendations, as well, and they are reviewed here.

2011-2012 vaccine choices include a new product

Although the virus strains in the 2011-2012 vaccines are the same as in 2010-2011²—A/California/7/2009 (H1N1)-like, A/Perth/16/ 2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens—individuals vaccinated last year should receive the vaccine again this year. Over the course of a year, antibodies that developed in response to an influenza vaccine decline, and it is believed that even if the vaccine strains have not changed, annual vaccination confers optimal protection.

Although all influenza vaccine products available in the United States contain the same virus strains, the products contain either killed virus (trivalent influenza vaccine [TIV]) or live virus (live attenuated influenza vaccine [LAIV]). The only LAIV vaccine available is the intranasally administered FluMist (MedImmune). It is licensed for use in those between the ages of 2 and 49 years who are healthy, nonpregnant, and without high-risk medical conditions. The CDC does not state a preference for LAIV or TIV in this age group.

A new intradermally administered TIV, Fluzone Intradermal (Sanofi Pasteur),³ was licensed in May 2011 for use in individuals ages 18 through 64 years. It contains less antigen than intramuscular TIV options and is administered in a smaller volume (0.1 rather than 0.5 mL). The preferred site of administration is over the deltoid muscle. Injection-site erythema, induration, swelling, and pruritus occur more frequently than with intramuscular vaccine, but usually these reactions are self-limited, resolving within 3 to 7 days.

Again this coming season, a higher antigen product, Fluzone High-Dose (Sanofi Pasteur), will be available for adults ages 65 and older.⁴ Fluzone High-Dose contains 4 times the amount of influenza antigen as other TIV options. Ongoing studies are comparing this product with others for effectiveness and rates of adverse reactions. At this time, however, ACIP has not identified a preferred TIV product for this age group.

Easier decision making with young children
How to determine the number of doses needed by a child younger than 9 years has been simplified. If the child received 1 or more doses of vaccine last season, only 1 dose is needed this year. If no vaccine was received last year or if that status is unknown, 2 doses are recommended (FIGURE).¹

FIGURE
How many doses of flu vaccine for children 6 months through 8 years of age?¹

Egg allergy does not necessarily prohibit vaccination
The last recommendation change this season is that a history of egg allergy is no longer an automatic contraindication to influenza vaccine.¹ The only contraindication to receiving the vaccine is a prior severe allergic reaction to influenza vaccine. ACIP now states that individuals who have experienced only hives after exposure to egg should receive the vaccine, but only a TIV product and only from a health care provider who is familiar with the potential manifestations of egg allergy. Additionally, those who receive the vaccine should be observed for at least 30 minutes for signs of a reaction.

In the past, some providers have used a 2-step approach (giving a small proportion as a dose first; then, if no reaction occurs, administering the remaining portion). Others have recommended skin testing with vaccine before administration. Neither of these approaches is necessary, according to ACIP, which cites studies that showed skin prick testing with vaccine is poorly predictive of allergic reactions and administration of both full doses and 2-step doses have been well tolerated.¹

Many people reporting egg allergy will not have a reaction to influenza vaccine.¹ In addition, current influenza vaccine products contain very low levels of egg protein. Individuals more likely to have a serious reaction are those who have had severe reactions to egg—eg, angioedema, respiratory distress, light-headedness, or recurrent emesis, or who required epinephrine or other emergency medical interventions. Such people should be referred to a physician with expertise in the management of allergic conditions for further risk assessment.¹ As another precaution, the ACIP recommendations state that all vaccines should be administered in settings where equipment is on hand for treatment of anaphylaxis and where providers are trained in the recognition and treatment of allergic reactions.

The Centers for Disease Control and Prevention (CDC) has released recommendations made by the Advisory Committee for Immunization Practices (ACIP) for using influenza vaccine for the upcoming influenza season.¹ The recommendations, which are easier to follow than in past years, continue to advise that patients older than 6 months of age (without a contraindication) be vaccinated annually. But there are some newer recommendations, as well, and they are reviewed here.

2011-2012 vaccine choices include a new product

Although the virus strains in the 2011-2012 vaccines are the same as in 2010-2011²—A/California/7/2009 (H1N1)-like, A/Perth/16/ 2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens—individuals vaccinated last year should receive the vaccine again this year. Over the course of a year, antibodies that developed in response to an influenza vaccine decline, and it is believed that even if the vaccine strains have not changed, annual vaccination confers optimal protection.

Although all influenza vaccine products available in the United States contain the same virus strains, the products contain either killed virus (trivalent influenza vaccine [TIV]) or live virus (live attenuated influenza vaccine [LAIV]). The only LAIV vaccine available is the intranasally administered FluMist (MedImmune). It is licensed for use in those between the ages of 2 and 49 years who are healthy, nonpregnant, and without high-risk medical conditions. The CDC does not state a preference for LAIV or TIV in this age group.

A new intradermally administered TIV, Fluzone Intradermal (Sanofi Pasteur),³ was licensed in May 2011 for use in individuals ages 18 through 64 years. It contains less antigen than intramuscular TIV options and is administered in a smaller volume (0.1 rather than 0.5 mL). The preferred site of administration is over the deltoid muscle. Injection-site erythema, induration, swelling, and pruritus occur more frequently than with intramuscular vaccine, but usually these reactions are self-limited, resolving within 3 to 7 days.

Again this coming season, a higher antigen product, Fluzone High-Dose (Sanofi Pasteur), will be available for adults ages 65 and older.⁴ Fluzone High-Dose contains 4 times the amount of influenza antigen as other TIV options. Ongoing studies are comparing this product with others for effectiveness and rates of adverse reactions. At this time, however, ACIP has not identified a preferred TIV product for this age group.

Easier decision making with young children
How to determine the number of doses needed by a child younger than 9 years has been simplified. If the child received 1 or more doses of vaccine last season, only 1 dose is needed this year. If no vaccine was received last year or if that status is unknown, 2 doses are recommended (FIGURE).¹

FIGURE
How many doses of flu vaccine for children 6 months through 8 years of age?¹

Egg allergy does not necessarily prohibit vaccination
The last recommendation change this season is that a history of egg allergy is no longer an automatic contraindication to influenza vaccine.¹ The only contraindication to receiving the vaccine is a prior severe allergic reaction to influenza vaccine. ACIP now states that individuals who have experienced only hives after exposure to egg should receive the vaccine, but only a TIV product and only from a health care provider who is familiar with the potential manifestations of egg allergy. Additionally, those who receive the vaccine should be observed for at least 30 minutes for signs of a reaction.

In the past, some providers have used a 2-step approach (giving a small proportion as a dose first; then, if no reaction occurs, administering the remaining portion). Others have recommended skin testing with vaccine before administration. Neither of these approaches is necessary, according to ACIP, which cites studies that showed skin prick testing with vaccine is poorly predictive of allergic reactions and administration of both full doses and 2-step doses have been well tolerated.¹

Many people reporting egg allergy will not have a reaction to influenza vaccine.¹ In addition, current influenza vaccine products contain very low levels of egg protein. Individuals more likely to have a serious reaction are those who have had severe reactions to egg—eg, angioedema, respiratory distress, light-headedness, or recurrent emesis, or who required epinephrine or other emergency medical interventions. Such people should be referred to a physician with expertise in the management of allergic conditions for further risk assessment.¹ As another precaution, the ACIP recommendations state that all vaccines should be administered in settings where equipment is on hand for treatment of anaphylaxis and where providers are trained in the recognition and treatment of allergic reactions.

Nearly 3 out of 4 (71.9%) US women (and 72.6% of men) ages 60 to 79 years have cardiovascular disease (CVD)—the leading cause of death despite marked improvement in mortality rates in the last 4 decades. In that same age group, the prevalence of cerebral vascular disease is 8.2% in women and 7.2% in men.¹

The age-adjusted death rate for all adults is 135.1 in 100,000 for coronary heart disease (CHD) and 44.1 in 100,000 for cerebral vascular disease. In 2007, CVD caused 34.5% of deaths in women and 32.7% of deaths in men.¹

Evidence that CVD frequently manifests differently in women than in men led the American Heart Association (AHA) to issue recommendations for the prevention of CVD in women in 1999, and to follow with guidelines in 2004 and an update in 2007.^2-4 However, the recommended interventions were, with a few exceptions, the same as the recommendations for men. But that’s changed.

The latest update of the guidelines, published earlier this year, focuses more on sex-based differences, with the addition of pregnancy complications as a major risk factor, for example. (See “AHA’s 2011 CVD guideline update: What’s new?”.) Highlights of the guidelines,⁵ including the recommended interventions for all women (TABLE 1) and a comparison of its recommendations with those of the US Preventive Services Task Force (USPSTF)⁶ (TABLE 2)—are detailed here.

TABLE 1
AHA recommends these interventions for all women⁵

TABLE 2
CVD prevention in women: Comparing AHA¹and USPSTF recommendations^5,6

The AHA’s assessment of risk

The new guideline update recommends assessing each woman’s CVD risk and placing her into one of 3 risk groups—high risk, at risk, and ideal cardiovascular health (TABLE 3)—then using an algorithm to determine which preventive interventions to recommend based on her risk level.

This classification approach is challenging, for several reasons. It lumps women with markedly different risk profiles into the “at risk” group, a category that will likely apply to a high proportion of women. It also appears to encourage the use of diagnostic tests for subclinical vascular disease, for which there is no evidence of effectiveness. In addition, some of the terms used in the at-risk criteria, such as ”physical inactivity” and “poor diet,” are vague.

TABLE 3
Cardiovascular disease: How the AHA classifies women’s risk⁵

Some recommendations apply to all women, regardless of risk
The AHA recommendations for all women (TABLE 1) include smoking prevention or cessation, maintenance of optimal weight, regular physical activity, and a diet aimed at preventing CVD. The guidelines also emphasize that major CVD risks should be controlled, with either lifestyle and diet modifications (preferably) or pharmacotherapy. The aggressiveness of control targets depends on the level of risk and the presence of other risk factors.

The guidelines recommend against some interventions that are often used for CVD prevention, based on a high level of evidence that they are ineffective. These include estrogen or selective estrogen receptor modulators, antioxidant vitamins (vitamins E and C, and beta-carotene), folic acid with or without vitamins B6 and B12, and aspirin (for CHD prevention) for healthy women <65 years old.

The AHA does not take a position for or against several diagnostic and risk classification tools because of a lack of evidence of usefulness. These include CVD risk biomarkers such as high sensitivity C-reactive protein and imaging technologies such as coronary calcium scoring assessment.

AHA and USPSTF diverge, but not by much

Screening for conditions that increase CVD risk is not explicitly addressed in the AHA guidelines. Screening is implied by the proposed classification scheme, which includes the presence or absence of smoking, obesity, diabetes, hypertension, and dyslipidemia, but there is no guidance on when to start or stop screening for these conditions. The AHA and the USPSTF diverge on screening women for dyslipidemia, with the USPSTF recommending screening for lipid disorders only in women at increased risk for CHD.

The recommendations for optimal weight and activity levels in the AHA guidelines do not include advice on how to achieve them, nor do they call for an assessment of the effectiveness of behavioral counseling in the clinical setting. Because the USPSTF includes an assessment of, and recommendations for, asymptomatic patients in primary care settings, its recommendations do not address women with conditions such as established CVD, heart failure, or atrial fibrillation—which the AHA guidelines do.

Overall, the AHA and USPSTF agree more than they disagree, and each covers some areas that the other does not (TABLE 2). Family physicians can use the information provided by both entities to ensure that their female patients receive high-quality preventive care that will minimize their risk for CVD.

Nearly 3 out of 4 (71.9%) US women (and 72.6% of men) ages 60 to 79 years have cardiovascular disease (CVD)—the leading cause of death despite marked improvement in mortality rates in the last 4 decades. In that same age group, the prevalence of cerebral vascular disease is 8.2% in women and 7.2% in men.¹

The age-adjusted death rate for all adults is 135.1 in 100,000 for coronary heart disease (CHD) and 44.1 in 100,000 for cerebral vascular disease. In 2007, CVD caused 34.5% of deaths in women and 32.7% of deaths in men.¹

Evidence that CVD frequently manifests differently in women than in men led the American Heart Association (AHA) to issue recommendations for the prevention of CVD in women in 1999, and to follow with guidelines in 2004 and an update in 2007.^2-4 However, the recommended interventions were, with a few exceptions, the same as the recommendations for men. But that’s changed.

The latest update of the guidelines, published earlier this year, focuses more on sex-based differences, with the addition of pregnancy complications as a major risk factor, for example. (See “AHA’s 2011 CVD guideline update: What’s new?”.) Highlights of the guidelines,⁵ including the recommended interventions for all women (TABLE 1) and a comparison of its recommendations with those of the US Preventive Services Task Force (USPSTF)⁶ (TABLE 2)—are detailed here.

TABLE 1
AHA recommends these interventions for all women⁵

TABLE 2
CVD prevention in women: Comparing AHA¹and USPSTF recommendations^5,6

The AHA’s assessment of risk

The new guideline update recommends assessing each woman’s CVD risk and placing her into one of 3 risk groups—high risk, at risk, and ideal cardiovascular health (TABLE 3)—then using an algorithm to determine which preventive interventions to recommend based on her risk level.

This classification approach is challenging, for several reasons. It lumps women with markedly different risk profiles into the “at risk” group, a category that will likely apply to a high proportion of women. It also appears to encourage the use of diagnostic tests for subclinical vascular disease, for which there is no evidence of effectiveness. In addition, some of the terms used in the at-risk criteria, such as ”physical inactivity” and “poor diet,” are vague.

TABLE 3
Cardiovascular disease: How the AHA classifies women’s risk⁵

Some recommendations apply to all women, regardless of risk
The AHA recommendations for all women (TABLE 1) include smoking prevention or cessation, maintenance of optimal weight, regular physical activity, and a diet aimed at preventing CVD. The guidelines also emphasize that major CVD risks should be controlled, with either lifestyle and diet modifications (preferably) or pharmacotherapy. The aggressiveness of control targets depends on the level of risk and the presence of other risk factors.

The guidelines recommend against some interventions that are often used for CVD prevention, based on a high level of evidence that they are ineffective. These include estrogen or selective estrogen receptor modulators, antioxidant vitamins (vitamins E and C, and beta-carotene), folic acid with or without vitamins B6 and B12, and aspirin (for CHD prevention) for healthy women <65 years old.

The AHA does not take a position for or against several diagnostic and risk classification tools because of a lack of evidence of usefulness. These include CVD risk biomarkers such as high sensitivity C-reactive protein and imaging technologies such as coronary calcium scoring assessment.

AHA and USPSTF diverge, but not by much

Screening for conditions that increase CVD risk is not explicitly addressed in the AHA guidelines. Screening is implied by the proposed classification scheme, which includes the presence or absence of smoking, obesity, diabetes, hypertension, and dyslipidemia, but there is no guidance on when to start or stop screening for these conditions. The AHA and the USPSTF diverge on screening women for dyslipidemia, with the USPSTF recommending screening for lipid disorders only in women at increased risk for CHD.

The recommendations for optimal weight and activity levels in the AHA guidelines do not include advice on how to achieve them, nor do they call for an assessment of the effectiveness of behavioral counseling in the clinical setting. Because the USPSTF includes an assessment of, and recommendations for, asymptomatic patients in primary care settings, its recommendations do not address women with conditions such as established CVD, heart failure, or atrial fibrillation—which the AHA guidelines do.

Overall, the AHA and USPSTF agree more than they disagree, and each covers some areas that the other does not (TABLE 2). Family physicians can use the information provided by both entities to ensure that their female patients receive high-quality preventive care that will minimize their risk for CVD.

Nearly 3 out of 4 (71.9%) US women (and 72.6% of men) ages 60 to 79 years have cardiovascular disease (CVD)—the leading cause of death despite marked improvement in mortality rates in the last 4 decades. In that same age group, the prevalence of cerebral vascular disease is 8.2% in women and 7.2% in men.¹

The age-adjusted death rate for all adults is 135.1 in 100,000 for coronary heart disease (CHD) and 44.1 in 100,000 for cerebral vascular disease. In 2007, CVD caused 34.5% of deaths in women and 32.7% of deaths in men.¹

Evidence that CVD frequently manifests differently in women than in men led the American Heart Association (AHA) to issue recommendations for the prevention of CVD in women in 1999, and to follow with guidelines in 2004 and an update in 2007.^2-4 However, the recommended interventions were, with a few exceptions, the same as the recommendations for men. But that’s changed.

The latest update of the guidelines, published earlier this year, focuses more on sex-based differences, with the addition of pregnancy complications as a major risk factor, for example. (See “AHA’s 2011 CVD guideline update: What’s new?”.) Highlights of the guidelines,⁵ including the recommended interventions for all women (TABLE 1) and a comparison of its recommendations with those of the US Preventive Services Task Force (USPSTF)⁶ (TABLE 2)—are detailed here.

TABLE 1
AHA recommends these interventions for all women⁵

TABLE 2
CVD prevention in women: Comparing AHA¹and USPSTF recommendations^5,6

The AHA’s assessment of risk

The new guideline update recommends assessing each woman’s CVD risk and placing her into one of 3 risk groups—high risk, at risk, and ideal cardiovascular health (TABLE 3)—then using an algorithm to determine which preventive interventions to recommend based on her risk level.

This classification approach is challenging, for several reasons. It lumps women with markedly different risk profiles into the “at risk” group, a category that will likely apply to a high proportion of women. It also appears to encourage the use of diagnostic tests for subclinical vascular disease, for which there is no evidence of effectiveness. In addition, some of the terms used in the at-risk criteria, such as ”physical inactivity” and “poor diet,” are vague.

TABLE 3
Cardiovascular disease: How the AHA classifies women’s risk⁵

Some recommendations apply to all women, regardless of risk
The AHA recommendations for all women (TABLE 1) include smoking prevention or cessation, maintenance of optimal weight, regular physical activity, and a diet aimed at preventing CVD. The guidelines also emphasize that major CVD risks should be controlled, with either lifestyle and diet modifications (preferably) or pharmacotherapy. The aggressiveness of control targets depends on the level of risk and the presence of other risk factors.

The guidelines recommend against some interventions that are often used for CVD prevention, based on a high level of evidence that they are ineffective. These include estrogen or selective estrogen receptor modulators, antioxidant vitamins (vitamins E and C, and beta-carotene), folic acid with or without vitamins B6 and B12, and aspirin (for CHD prevention) for healthy women <65 years old.

The AHA does not take a position for or against several diagnostic and risk classification tools because of a lack of evidence of usefulness. These include CVD risk biomarkers such as high sensitivity C-reactive protein and imaging technologies such as coronary calcium scoring assessment.

AHA and USPSTF diverge, but not by much

Screening for conditions that increase CVD risk is not explicitly addressed in the AHA guidelines. Screening is implied by the proposed classification scheme, which includes the presence or absence of smoking, obesity, diabetes, hypertension, and dyslipidemia, but there is no guidance on when to start or stop screening for these conditions. The AHA and the USPSTF diverge on screening women for dyslipidemia, with the USPSTF recommending screening for lipid disorders only in women at increased risk for CHD.

The recommendations for optimal weight and activity levels in the AHA guidelines do not include advice on how to achieve them, nor do they call for an assessment of the effectiveness of behavioral counseling in the clinical setting. Because the USPSTF includes an assessment of, and recommendations for, asymptomatic patients in primary care settings, its recommendations do not address women with conditions such as established CVD, heart failure, or atrial fibrillation—which the AHA guidelines do.

Overall, the AHA and USPSTF agree more than they disagree, and each covers some areas that the other does not (TABLE 2). Family physicians can use the information provided by both entities to ensure that their female patients receive high-quality preventive care that will minimize their risk for CVD.

Keeping up with the ever-changing immunization schedules recommended by the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) can be difficult. The most recent changes are the interim recommendations from the February 2011 ACIP meeting pertaining to tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine immunization and postexposure prophylaxis (PEP) for health care personnel. Updated schedules for routine immunization of children and adults that incorporate additions and changes made in the preceding year were published by the CDC in February.^1,2

ACIP widens the scope of pertussis prevention

The past decade has seen an increase in pertussis cases, including an increase in the number of cases among infants and adolescents (FIGURE). In 2010, California reported 8383 cases, including 10 infant deaths. This was the highest number and rate of cases reported in more than 50 years.³ Other states have also experienced recent increases.

This evolving epidemiology of pertussis has prompted ACIP to recommend a routine single Tdap dose for adolescents between the ages of 11 and 18 years who have completed the recommended DTP/DTaP (diphtheria and tetanus toxoids and pertussis/diphtheria and tetanus toxoids and acellular pertussis) vaccination series and for adults ages 19 to 64 years. ACIP also recommends a single dose for children ages 7 to 10 if they are not fully vaccinated against pertussis and for adults 65 and older who have not previously received Tdap and who are in close contact with infants. The last 2 are off-label recommendations. ACIP has also eliminated any recommended interval between the time of vaccination with tetanus or diphtheriatoxoid (Td) containing vaccine and the administration of Tdap.⁴

FIGURE
Reported pertussis incidence by age group, 1990-2009

2 new recommendations for clinician postexposure prophylaxis

Interim recommendations from the most recent ACIP meeting in February 2011⁵ re-emphasize that health care personnel should receive Tdap and recommend that health care facilities take steps to increase adherence, including providing the vaccine at no cost.⁵

Since health care personnel are at increased risk of exposure to pertussis, ACIP also made 2 recommendations for PEP.

1. All health care personnel (vaccinated or not) in close contact with a pertussis patient (as defined in TABLE 1) who are likely to expose patients at high risk for complications from pertussis (infants <1 year of age and those with certain immunodeficiency conditions, chronic lung disease, respiratory insufficiency, or cystic fibrosis) should receive PEP.
2. Exposed personnel who do not work with high-risk patients should receive PEP or be monitored daily for 21 days, treated at first signs of infection, and excluded from patient contact for 5 days if symptoms develop. The antimicrobials and doses for treatment and prevention of pertussis have been published in the Morbidity and Mortality Weekly Report.⁶ Options for PEP include azithromycin, clarithromycin, erythromycin, and trimethoprim-sulfamethoxazole.⁶

TABLE 1
Definition of close contact with a pertussis patient

Coming soon: Complete vaccine recommendations for health care workers
Recent experience with pertussis (and influenza) has highlighted the need for health care personnel to be vaccinated against infectious diseases to protect themselves, their patients, and their families. To that end, ACIP plans to publish a compendium later this year that brings together all recommendations regarding immunizations for health care personnel. When it becomes available, family physicians will be able to refer to this document to ensure that they and their staff are immunized in line with CDC recommendations.

The latest on influenza vaccine, PCV13, MCV4, hepatitis B, and HPV

The most notable additions to the routine schedules ACIP announced during the past year are universal, yearly influenza immunization from the age of 6 months on and the replacement of the 7-valent pneumococcal conjugate vaccine (PCV7) with a 13-valent product (PCV13) for infants and children. Details of these recommendations, including how to transition from PCV7 to PCV13, were published late last year by the CDC and described in another Practice Alert.^7-9

In addition, changes were made in the schedules for meningococcal conjugate vaccine. A 2-dose primary series, instead of a single dose, of MCV4 is now recommended for those with compromised immunity. A booster of MCV4 is now recommended at age 16 for those vaccinated at 11 or 12 years, and at age 16 to 18 for those vaccinated at 13 to 15 years.¹⁰ The MCV4 recommendations are summarized in TABLE 2.

More schedule details in the footnotes. The new schedules contain a number of clarifications in the footnotes that:^1,11

• explain the spacing of the 3-dose primary series for hepatitis B vaccine (HepB) for infants if they do not receive a dose immediately after birth
• clarify the circumstances in which children younger than age 9 need 2 doses of influenza vaccine
• describe the availability of both a quadrivalent human papillomavirus vaccine (HPV4) and a bivalent vaccine (HPV2) to prevent precancerous cervical lesions and cancer
• list the option for using HPV4 for males for the prevention of genital warts.

TABLE 2
Meningococcal conjugate vaccine recommendations by risk group, ACIP 2010

Keeping up with the ever-changing immunization schedules recommended by the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) can be difficult. The most recent changes are the interim recommendations from the February 2011 ACIP meeting pertaining to tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine immunization and postexposure prophylaxis (PEP) for health care personnel. Updated schedules for routine immunization of children and adults that incorporate additions and changes made in the preceding year were published by the CDC in February.^1,2

ACIP widens the scope of pertussis prevention

The past decade has seen an increase in pertussis cases, including an increase in the number of cases among infants and adolescents (FIGURE). In 2010, California reported 8383 cases, including 10 infant deaths. This was the highest number and rate of cases reported in more than 50 years.³ Other states have also experienced recent increases.

This evolving epidemiology of pertussis has prompted ACIP to recommend a routine single Tdap dose for adolescents between the ages of 11 and 18 years who have completed the recommended DTP/DTaP (diphtheria and tetanus toxoids and pertussis/diphtheria and tetanus toxoids and acellular pertussis) vaccination series and for adults ages 19 to 64 years. ACIP also recommends a single dose for children ages 7 to 10 if they are not fully vaccinated against pertussis and for adults 65 and older who have not previously received Tdap and who are in close contact with infants. The last 2 are off-label recommendations. ACIP has also eliminated any recommended interval between the time of vaccination with tetanus or diphtheriatoxoid (Td) containing vaccine and the administration of Tdap.⁴

FIGURE
Reported pertussis incidence by age group, 1990-2009

2 new recommendations for clinician postexposure prophylaxis

Interim recommendations from the most recent ACIP meeting in February 2011⁵ re-emphasize that health care personnel should receive Tdap and recommend that health care facilities take steps to increase adherence, including providing the vaccine at no cost.⁵

Since health care personnel are at increased risk of exposure to pertussis, ACIP also made 2 recommendations for PEP.

1. All health care personnel (vaccinated or not) in close contact with a pertussis patient (as defined in TABLE 1) who are likely to expose patients at high risk for complications from pertussis (infants <1 year of age and those with certain immunodeficiency conditions, chronic lung disease, respiratory insufficiency, or cystic fibrosis) should receive PEP.
2. Exposed personnel who do not work with high-risk patients should receive PEP or be monitored daily for 21 days, treated at first signs of infection, and excluded from patient contact for 5 days if symptoms develop. The antimicrobials and doses for treatment and prevention of pertussis have been published in the Morbidity and Mortality Weekly Report.⁶ Options for PEP include azithromycin, clarithromycin, erythromycin, and trimethoprim-sulfamethoxazole.⁶

TABLE 1
Definition of close contact with a pertussis patient

Coming soon: Complete vaccine recommendations for health care workers
Recent experience with pertussis (and influenza) has highlighted the need for health care personnel to be vaccinated against infectious diseases to protect themselves, their patients, and their families. To that end, ACIP plans to publish a compendium later this year that brings together all recommendations regarding immunizations for health care personnel. When it becomes available, family physicians will be able to refer to this document to ensure that they and their staff are immunized in line with CDC recommendations.

The latest on influenza vaccine, PCV13, MCV4, hepatitis B, and HPV

The most notable additions to the routine schedules ACIP announced during the past year are universal, yearly influenza immunization from the age of 6 months on and the replacement of the 7-valent pneumococcal conjugate vaccine (PCV7) with a 13-valent product (PCV13) for infants and children. Details of these recommendations, including how to transition from PCV7 to PCV13, were published late last year by the CDC and described in another Practice Alert.^7-9

In addition, changes were made in the schedules for meningococcal conjugate vaccine. A 2-dose primary series, instead of a single dose, of MCV4 is now recommended for those with compromised immunity. A booster of MCV4 is now recommended at age 16 for those vaccinated at 11 or 12 years, and at age 16 to 18 for those vaccinated at 13 to 15 years.¹⁰ The MCV4 recommendations are summarized in TABLE 2.

More schedule details in the footnotes. The new schedules contain a number of clarifications in the footnotes that:^1,11

• explain the spacing of the 3-dose primary series for hepatitis B vaccine (HepB) for infants if they do not receive a dose immediately after birth
• clarify the circumstances in which children younger than age 9 need 2 doses of influenza vaccine
• describe the availability of both a quadrivalent human papillomavirus vaccine (HPV4) and a bivalent vaccine (HPV2) to prevent precancerous cervical lesions and cancer
• list the option for using HPV4 for males for the prevention of genital warts.

TABLE 2
Meningococcal conjugate vaccine recommendations by risk group, ACIP 2010

Keeping up with the ever-changing immunization schedules recommended by the Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) can be difficult. The most recent changes are the interim recommendations from the February 2011 ACIP meeting pertaining to tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine immunization and postexposure prophylaxis (PEP) for health care personnel. Updated schedules for routine immunization of children and adults that incorporate additions and changes made in the preceding year were published by the CDC in February.^1,2

ACIP widens the scope of pertussis prevention

The past decade has seen an increase in pertussis cases, including an increase in the number of cases among infants and adolescents (FIGURE). In 2010, California reported 8383 cases, including 10 infant deaths. This was the highest number and rate of cases reported in more than 50 years.³ Other states have also experienced recent increases.

This evolving epidemiology of pertussis has prompted ACIP to recommend a routine single Tdap dose for adolescents between the ages of 11 and 18 years who have completed the recommended DTP/DTaP (diphtheria and tetanus toxoids and pertussis/diphtheria and tetanus toxoids and acellular pertussis) vaccination series and for adults ages 19 to 64 years. ACIP also recommends a single dose for children ages 7 to 10 if they are not fully vaccinated against pertussis and for adults 65 and older who have not previously received Tdap and who are in close contact with infants. The last 2 are off-label recommendations. ACIP has also eliminated any recommended interval between the time of vaccination with tetanus or diphtheriatoxoid (Td) containing vaccine and the administration of Tdap.⁴

FIGURE
Reported pertussis incidence by age group, 1990-2009

2 new recommendations for clinician postexposure prophylaxis

Interim recommendations from the most recent ACIP meeting in February 2011⁵ re-emphasize that health care personnel should receive Tdap and recommend that health care facilities take steps to increase adherence, including providing the vaccine at no cost.⁵

Since health care personnel are at increased risk of exposure to pertussis, ACIP also made 2 recommendations for PEP.

1. All health care personnel (vaccinated or not) in close contact with a pertussis patient (as defined in TABLE 1) who are likely to expose patients at high risk for complications from pertussis (infants <1 year of age and those with certain immunodeficiency conditions, chronic lung disease, respiratory insufficiency, or cystic fibrosis) should receive PEP.
2. Exposed personnel who do not work with high-risk patients should receive PEP or be monitored daily for 21 days, treated at first signs of infection, and excluded from patient contact for 5 days if symptoms develop. The antimicrobials and doses for treatment and prevention of pertussis have been published in the Morbidity and Mortality Weekly Report.⁶ Options for PEP include azithromycin, clarithromycin, erythromycin, and trimethoprim-sulfamethoxazole.⁶

TABLE 1
Definition of close contact with a pertussis patient

Coming soon: Complete vaccine recommendations for health care workers
Recent experience with pertussis (and influenza) has highlighted the need for health care personnel to be vaccinated against infectious diseases to protect themselves, their patients, and their families. To that end, ACIP plans to publish a compendium later this year that brings together all recommendations regarding immunizations for health care personnel. When it becomes available, family physicians will be able to refer to this document to ensure that they and their staff are immunized in line with CDC recommendations.

The latest on influenza vaccine, PCV13, MCV4, hepatitis B, and HPV

The most notable additions to the routine schedules ACIP announced during the past year are universal, yearly influenza immunization from the age of 6 months on and the replacement of the 7-valent pneumococcal conjugate vaccine (PCV7) with a 13-valent product (PCV13) for infants and children. Details of these recommendations, including how to transition from PCV7 to PCV13, were published late last year by the CDC and described in another Practice Alert.^7-9

In addition, changes were made in the schedules for meningococcal conjugate vaccine. A 2-dose primary series, instead of a single dose, of MCV4 is now recommended for those with compromised immunity. A booster of MCV4 is now recommended at age 16 for those vaccinated at 11 or 12 years, and at age 16 to 18 for those vaccinated at 13 to 15 years.¹⁰ The MCV4 recommendations are summarized in TABLE 2.

More schedule details in the footnotes. The new schedules contain a number of clarifications in the footnotes that:^1,11

• explain the spacing of the 3-dose primary series for hepatitis B vaccine (HepB) for infants if they do not receive a dose immediately after birth
• clarify the circumstances in which children younger than age 9 need 2 doses of influenza vaccine
• describe the availability of both a quadrivalent human papillomavirus vaccine (HPV4) and a bivalent vaccine (HPV2) to prevent precancerous cervical lesions and cancer
• list the option for using HPV4 for males for the prevention of genital warts.

TABLE 2
Meningococcal conjugate vaccine recommendations by risk group, ACIP 2010

In 2010, the CDC released an update of its Sexually Transmitted Diseases (STD) Treatment Guidelines,¹ which were last updated in 2006. The guidelines are widely viewed as the most authoritative source of information on the diagnosis, treatment, and follow-up of STDs, and they are the standard for publicly and privately funded clinics focusing on sexual health.

What’s new

Some of the notable changes made since the last update in 2006 appear in TABLE 1.^1,2

Uncomplicated gonorrhea. Cephalosporins are the only class of antibiotic recommended as first-line treatment for gonorrhea. (In a 2007 recommendation revision, the CDC opted to no longer recommend quinolone antibiotics for the treatment of gonorrhea, because of widespread bacterial resistance.³) Preference is now given to ceftriaxone because of its proven effectiveness against pharyngeal infection, which is often asymptomatic, difficult to detect, and difficult to eradicate. Additionally, the 2010 update has increased the recommended dose of ceftriazone from 125 to 250 mg intramuscularly. The larger dose is more effective against pharyngeal infection; it is also a safeguard against decreased bacterial susceptibility to cephalosporins, which, although still very low, has been reported in more cases recently.

The guidelines still recommend that azithromycin, 1 g orally in a single dose, be given with ceftriaxone because of the relatively high rate of co-infection with Chlamydia trachomatis and the potential for azithromycin to assist with eradicating any gonorrhea with decreased susceptibility to ceftriaxone.

Pelvic inflammatory disease. Quinolones have also been removed from the list of options for outpatient treatment of pelvic inflammatory disease. All recommended regimens now specify a parenteral cephalosporin as a single injection with doxycycline 100 mg PO twice a day for 14 days, with or without metronidazole 500 mg PO twice a day for 14 days.

Bacterial vaginosis. Tinidazole, 2 g orally once a day for 2 days or 1 g orally once a day for 5 days, is now an alternative agent for bacterial vaginosis. However, preferred treatments remain metronidazole 500 mg orally twice a day for 7 days, metronidazole gel intravaginally once a day for 5 days, or clindamycin cream intravaginally at bedtime for 7 days.

Newborn gonococcal eye infection. A relatively minor change is the elimination of tetracycline as prophylaxis for newborn gonococcal eye infections, leaving only erythromycin ointment to prevent the condition.

TABLE 1
2010 vs 2006: How have the CDC recommendations for STD treatment changed?^1,2

Single-dose therapy preferred among equivalent options

Single-dose therapy (TABLE 2), while often more expensive than other options, increases compliance and helps ensure treatment completion. Single-dose therapy administered in your office is essentially directly observed treatment, an intervention that has become the standard of care for other diseases such as tuberculosis. If the single-dose agent is as effective as alternative medications, directly observed on-site administration is the preferred option for treating STDs.

TABLE 2
Single-dose therapies for specific STDs¹

Other guideline recommendations
The CDC’s STD treatment guidelines contain a wealth of useful information beyond treatment advice: recommended methods of confirming diagnoses, analyses of the usefulness of various diagnostic tests, recommendations on how to manage sex partners of those infected, guidance on STD prevention counseling, and considerations for special populations and circumstances.

Additionally, there is a section on screening for STDs reflecting recommendations of the US Preventive Services Task Force (USPSTF); it also includes recommendations from the American College of Obstetricians and Gynecologists. In at least one instance, though, the USPSTF recommendation on screening for HIV infection contradicts other CDC sources.^4,5 Also included is guidance on using vaccines to prevent hepatitis A, hepatitis B, and human papillomavirus (HPV), which follows the recommendations of the Advisory Committee on Immunization Practices. When to use DNA testing to detect HPV is described briefly.

A shortcoming of the CDC guidelines
Although the CDC’s STD guidelines remain the most authoritative source of information on the diagnosis and treatment of STDs, they do not seem to use a consistent method for assessing and describing the strength of the evidence behind the recommendations, which family physicians have come to expect. (However, it is sometimes possible to discern the type and strength of evidence for a particular recommendation from the written discussion.)

The new guidelines state that a series of papers to be published in Clinical Infectious Diseases will describe more fully the evidence behind some of the recommendations and include evidence tables. However, in future guideline updates, it would be helpful if the CDC were to include a brief description of the quantity and strength of evidence alongside each recommended treatment option in the tables.

How best to keep up to date
Although the new guidelines summarize the current status of recommendations on the diagnosis, treatment, and prevention of STDs and are a useful resource for family physicians, we cannot stay current simply by referring to them alone over the next 4 to 5 years until a new edition is published. As new evidence develops, changes in recommendations will be published in the Morbidity and Mortality Weekly Report.

Case in point: new interim HIV recommendations. Interim recommendations were recently released on pre-exposure prophylaxis for men who have sex with men.⁶ (For more on these recommendations, check out this month’s audiocast at jfponline.com.) Final recommendations are expected later this year. Recommendations for post-exposure prophylaxis to prevent HIV infection are also expected soon.

In 2010, the CDC released an update of its Sexually Transmitted Diseases (STD) Treatment Guidelines,¹ which were last updated in 2006. The guidelines are widely viewed as the most authoritative source of information on the diagnosis, treatment, and follow-up of STDs, and they are the standard for publicly and privately funded clinics focusing on sexual health.

What’s new

Some of the notable changes made since the last update in 2006 appear in TABLE 1.^1,2

Uncomplicated gonorrhea. Cephalosporins are the only class of antibiotic recommended as first-line treatment for gonorrhea. (In a 2007 recommendation revision, the CDC opted to no longer recommend quinolone antibiotics for the treatment of gonorrhea, because of widespread bacterial resistance.³) Preference is now given to ceftriaxone because of its proven effectiveness against pharyngeal infection, which is often asymptomatic, difficult to detect, and difficult to eradicate. Additionally, the 2010 update has increased the recommended dose of ceftriazone from 125 to 250 mg intramuscularly. The larger dose is more effective against pharyngeal infection; it is also a safeguard against decreased bacterial susceptibility to cephalosporins, which, although still very low, has been reported in more cases recently.

The guidelines still recommend that azithromycin, 1 g orally in a single dose, be given with ceftriaxone because of the relatively high rate of co-infection with Chlamydia trachomatis and the potential for azithromycin to assist with eradicating any gonorrhea with decreased susceptibility to ceftriaxone.

Pelvic inflammatory disease. Quinolones have also been removed from the list of options for outpatient treatment of pelvic inflammatory disease. All recommended regimens now specify a parenteral cephalosporin as a single injection with doxycycline 100 mg PO twice a day for 14 days, with or without metronidazole 500 mg PO twice a day for 14 days.

Bacterial vaginosis. Tinidazole, 2 g orally once a day for 2 days or 1 g orally once a day for 5 days, is now an alternative agent for bacterial vaginosis. However, preferred treatments remain metronidazole 500 mg orally twice a day for 7 days, metronidazole gel intravaginally once a day for 5 days, or clindamycin cream intravaginally at bedtime for 7 days.

Newborn gonococcal eye infection. A relatively minor change is the elimination of tetracycline as prophylaxis for newborn gonococcal eye infections, leaving only erythromycin ointment to prevent the condition.

TABLE 1
2010 vs 2006: How have the CDC recommendations for STD treatment changed?^1,2

Single-dose therapy preferred among equivalent options

Single-dose therapy (TABLE 2), while often more expensive than other options, increases compliance and helps ensure treatment completion. Single-dose therapy administered in your office is essentially directly observed treatment, an intervention that has become the standard of care for other diseases such as tuberculosis. If the single-dose agent is as effective as alternative medications, directly observed on-site administration is the preferred option for treating STDs.

TABLE 2
Single-dose therapies for specific STDs¹

Other guideline recommendations
The CDC’s STD treatment guidelines contain a wealth of useful information beyond treatment advice: recommended methods of confirming diagnoses, analyses of the usefulness of various diagnostic tests, recommendations on how to manage sex partners of those infected, guidance on STD prevention counseling, and considerations for special populations and circumstances.

Additionally, there is a section on screening for STDs reflecting recommendations of the US Preventive Services Task Force (USPSTF); it also includes recommendations from the American College of Obstetricians and Gynecologists. In at least one instance, though, the USPSTF recommendation on screening for HIV infection contradicts other CDC sources.^4,5 Also included is guidance on using vaccines to prevent hepatitis A, hepatitis B, and human papillomavirus (HPV), which follows the recommendations of the Advisory Committee on Immunization Practices. When to use DNA testing to detect HPV is described briefly.

A shortcoming of the CDC guidelines
Although the CDC’s STD guidelines remain the most authoritative source of information on the diagnosis and treatment of STDs, they do not seem to use a consistent method for assessing and describing the strength of the evidence behind the recommendations, which family physicians have come to expect. (However, it is sometimes possible to discern the type and strength of evidence for a particular recommendation from the written discussion.)

The new guidelines state that a series of papers to be published in Clinical Infectious Diseases will describe more fully the evidence behind some of the recommendations and include evidence tables. However, in future guideline updates, it would be helpful if the CDC were to include a brief description of the quantity and strength of evidence alongside each recommended treatment option in the tables.

How best to keep up to date
Although the new guidelines summarize the current status of recommendations on the diagnosis, treatment, and prevention of STDs and are a useful resource for family physicians, we cannot stay current simply by referring to them alone over the next 4 to 5 years until a new edition is published. As new evidence develops, changes in recommendations will be published in the Morbidity and Mortality Weekly Report.

Case in point: new interim HIV recommendations. Interim recommendations were recently released on pre-exposure prophylaxis for men who have sex with men.⁶ (For more on these recommendations, check out this month’s audiocast at jfponline.com.) Final recommendations are expected later this year. Recommendations for post-exposure prophylaxis to prevent HIV infection are also expected soon.

In 2010, the CDC released an update of its Sexually Transmitted Diseases (STD) Treatment Guidelines,¹ which were last updated in 2006. The guidelines are widely viewed as the most authoritative source of information on the diagnosis, treatment, and follow-up of STDs, and they are the standard for publicly and privately funded clinics focusing on sexual health.

What’s new

Some of the notable changes made since the last update in 2006 appear in TABLE 1.^1,2

Uncomplicated gonorrhea. Cephalosporins are the only class of antibiotic recommended as first-line treatment for gonorrhea. (In a 2007 recommendation revision, the CDC opted to no longer recommend quinolone antibiotics for the treatment of gonorrhea, because of widespread bacterial resistance.³) Preference is now given to ceftriaxone because of its proven effectiveness against pharyngeal infection, which is often asymptomatic, difficult to detect, and difficult to eradicate. Additionally, the 2010 update has increased the recommended dose of ceftriazone from 125 to 250 mg intramuscularly. The larger dose is more effective against pharyngeal infection; it is also a safeguard against decreased bacterial susceptibility to cephalosporins, which, although still very low, has been reported in more cases recently.

The guidelines still recommend that azithromycin, 1 g orally in a single dose, be given with ceftriaxone because of the relatively high rate of co-infection with Chlamydia trachomatis and the potential for azithromycin to assist with eradicating any gonorrhea with decreased susceptibility to ceftriaxone.

Pelvic inflammatory disease. Quinolones have also been removed from the list of options for outpatient treatment of pelvic inflammatory disease. All recommended regimens now specify a parenteral cephalosporin as a single injection with doxycycline 100 mg PO twice a day for 14 days, with or without metronidazole 500 mg PO twice a day for 14 days.

Bacterial vaginosis. Tinidazole, 2 g orally once a day for 2 days or 1 g orally once a day for 5 days, is now an alternative agent for bacterial vaginosis. However, preferred treatments remain metronidazole 500 mg orally twice a day for 7 days, metronidazole gel intravaginally once a day for 5 days, or clindamycin cream intravaginally at bedtime for 7 days.

Newborn gonococcal eye infection. A relatively minor change is the elimination of tetracycline as prophylaxis for newborn gonococcal eye infections, leaving only erythromycin ointment to prevent the condition.

TABLE 1
2010 vs 2006: How have the CDC recommendations for STD treatment changed?^1,2

Single-dose therapy preferred among equivalent options

Single-dose therapy (TABLE 2), while often more expensive than other options, increases compliance and helps ensure treatment completion. Single-dose therapy administered in your office is essentially directly observed treatment, an intervention that has become the standard of care for other diseases such as tuberculosis. If the single-dose agent is as effective as alternative medications, directly observed on-site administration is the preferred option for treating STDs.

TABLE 2
Single-dose therapies for specific STDs¹

Other guideline recommendations
The CDC’s STD treatment guidelines contain a wealth of useful information beyond treatment advice: recommended methods of confirming diagnoses, analyses of the usefulness of various diagnostic tests, recommendations on how to manage sex partners of those infected, guidance on STD prevention counseling, and considerations for special populations and circumstances.

Additionally, there is a section on screening for STDs reflecting recommendations of the US Preventive Services Task Force (USPSTF); it also includes recommendations from the American College of Obstetricians and Gynecologists. In at least one instance, though, the USPSTF recommendation on screening for HIV infection contradicts other CDC sources.^4,5 Also included is guidance on using vaccines to prevent hepatitis A, hepatitis B, and human papillomavirus (HPV), which follows the recommendations of the Advisory Committee on Immunization Practices. When to use DNA testing to detect HPV is described briefly.

A shortcoming of the CDC guidelines
Although the CDC’s STD guidelines remain the most authoritative source of information on the diagnosis and treatment of STDs, they do not seem to use a consistent method for assessing and describing the strength of the evidence behind the recommendations, which family physicians have come to expect. (However, it is sometimes possible to discern the type and strength of evidence for a particular recommendation from the written discussion.)

The new guidelines state that a series of papers to be published in Clinical Infectious Diseases will describe more fully the evidence behind some of the recommendations and include evidence tables. However, in future guideline updates, it would be helpful if the CDC were to include a brief description of the quantity and strength of evidence alongside each recommended treatment option in the tables.

How best to keep up to date
Although the new guidelines summarize the current status of recommendations on the diagnosis, treatment, and prevention of STDs and are a useful resource for family physicians, we cannot stay current simply by referring to them alone over the next 4 to 5 years until a new edition is published. As new evidence develops, changes in recommendations will be published in the Morbidity and Mortality Weekly Report.

Case in point: new interim HIV recommendations. Interim recommendations were recently released on pre-exposure prophylaxis for men who have sex with men.⁶ (For more on these recommendations, check out this month’s audiocast at jfponline.com.) Final recommendations are expected later this year. Recommendations for post-exposure prophylaxis to prevent HIV infection are also expected soon.

At its October 2010 meeting, the Advisory Committee on Immunization Practices (ACIP) made 2 additions to its recommendations for quadrivalent meningococcal conjugate vaccine (MCV4), based on evolving knowledge of the vaccine and its duration of protection.

• A booster dose at age 16 has been added to the routine schedule for those vaccinated at ages 11 to 12 years. A booster dose has also been added for those vaccinated at ages 13 to 15 years, although the recommended timing of this booster had not been finalized at press time.
• A 2-dose primary series, 2 months apart, is now recommended for patients at higher risk of meningococcal disease. The high-risk category includes those with persistent complement component deficiency, asplenia, or human immunodeficiency virus (HIV). High-risk patients who were previously vaccinated should receive a booster dose at the earliest opportunity and continue to receive boosters at the appropriate interval (3-5 years).

Meningitis is rare but serious
Meningococcal meningitis is a potentially devastating disease in adolescents and young adults. It has a case fatality rate of about 20%, and the sequelae for survivors can be severe: 3.1% require limb amputations and another 10.9% suffer neurological deficits.¹ Thankfully, meningococcal disease is rare, occurring at rates below 1 in 200,000 in the 11- to 15-year-old age group and less than 1 in 100,000 in the 16- to 21-year-old age group.²

Routine immunization with MCV4 is recommended for adolescents
In 2007, ACIP recommended routine use of MCV4 for adolescents between the ages of 11 and 18 years. The recommendation gave preference to immunization at ages 11 to 12 years, along with the other adolescent vaccines given at that time.³ Updated recommendations in effect in 2010 state that those at highest risk for meningococcal infection (those with functional or anatomic asplenia, C3 complement deficiency, or HIV infection) should be vaccinated with MCV4 starting at age 2 and revaccinated every 3 years if last vaccinated at 2 to 6 years, and every 5 years if last vaccinated at or after age 7.^4,5 TABLE 1 lists the recommendations for MCV4 in place prior to the October 2010 ACIP meeting.

Two MCV4 products are licensed for use in the United States: Menactra (Sanofi Pasteur) and Menveo (Novartis). Both contain antigens against 4 serotypes, A, C, Y, and W-135. Neither protects against type B, which causes a majority of the disease in infants.⁶ In recent years, serotype A disease has become extremely rare in the United States.⁶ MCV4 coverage for adolescents ages 13 to 17 years is increasing, going from 41.8% in 2008 to 53.6% in 2009.⁷

TABLE 1
Recommendations for MCV4 prior to October 2010^3-5

The new recommendations: One is more controversial than the other

The recommendation for a 2-dose primary series in high-risk groups was not controversial. The same conditions that place individuals at highest risk for meningococcal infection also result in a less robust response to a single dose of the vaccine, and a 2-dose series is needed to achieve protective antibody levels in a high proportion of those vaccine recipients.⁸ This recommendation will affect relatively few patients.

The recommendation for booster doses in the general adolescent population generated a lot more debate. Studies performed since the licensure of MCV4 have shown that levels of protective antibodies decline over time. Five years after vaccination, 50% of vaccine recipients have levels below that considered fully protective.² One small case-control study of 107 cases suggested that the number of years from receipt of the vaccine was a risk factor for meningococcal disease.²

However, rates of meningococcal meningitis in adolescents have been declining over the past few years (TABLE 2), and there are no surveillance data to support the conclusion that teens vaccinated at ages 11 to 12 years are at increased risk as they age. In addition, the number of cases is very low (TABLE 3) and the cost benefit analysis of a booster dose of MCV4 is very unfavorable.^1,2

TABLE 2
Rates* of serogroup C, Y, and W-135 meningococcal disease^†

TABLE 3
Average annual number of cases of C, Y, and W-135 meningococcal disease

ACIP weighed the options for a booster dose
Three options were presented at the October 2010 ACIP meeting:

• Option 1: No change to the current recommendation for vaccination of 11- to 12-year-olds. Wait and see what happens to disease incidence over several more years.
• Option 2: Move the age of vaccination to 15 years with no booster. This would allow protection to persist through the years of highest risk (16-21 years).
• Option 3: Keep the recommendation for vaccination at ages 11 to 12 years, and add a booster dose at age 16.

The first option was the least cost effective: $281,000/quality-adjusted life year (QALY). The second option was the most cost effective at $121,000/QALY. The last option came out in the middle: $157,000/QALY, but it would save the most lives—9 more per year compared with Option 2.¹ There is, however, a caveat with regard to the cost-effectiveness estimates. The numbers were obtained using incidence data from the year 2000; incidence has declined since then, and cost-effectiveness estimates would be much less favorable using today’s rates.

These issues were discussed at length, and the decision to add a booster dose at age 16 was made on a close vote. This decision illustrates how difficult vaccine policy-making has become in recent years, when choices must be made about recommending safe, effective, and expensive vaccines to prevent illnesses that are both rare and serious.

The new MCV4 recommendations will be added to the child immunization schedule for 2011.

The take-home message for family physicians is to strive to increase the proportion of 11- to 12-year-olds who are fully vaccinated and in 2011 to begin to advise those who are between the ages of 16 and 20 years of the recommendation for a booster dose of MCV4.

At its October 2010 meeting, the Advisory Committee on Immunization Practices (ACIP) made 2 additions to its recommendations for quadrivalent meningococcal conjugate vaccine (MCV4), based on evolving knowledge of the vaccine and its duration of protection.

• A booster dose at age 16 has been added to the routine schedule for those vaccinated at ages 11 to 12 years. A booster dose has also been added for those vaccinated at ages 13 to 15 years, although the recommended timing of this booster had not been finalized at press time.
• A 2-dose primary series, 2 months apart, is now recommended for patients at higher risk of meningococcal disease. The high-risk category includes those with persistent complement component deficiency, asplenia, or human immunodeficiency virus (HIV). High-risk patients who were previously vaccinated should receive a booster dose at the earliest opportunity and continue to receive boosters at the appropriate interval (3-5 years).

Meningitis is rare but serious
Meningococcal meningitis is a potentially devastating disease in adolescents and young adults. It has a case fatality rate of about 20%, and the sequelae for survivors can be severe: 3.1% require limb amputations and another 10.9% suffer neurological deficits.¹ Thankfully, meningococcal disease is rare, occurring at rates below 1 in 200,000 in the 11- to 15-year-old age group and less than 1 in 100,000 in the 16- to 21-year-old age group.²

Routine immunization with MCV4 is recommended for adolescents
In 2007, ACIP recommended routine use of MCV4 for adolescents between the ages of 11 and 18 years. The recommendation gave preference to immunization at ages 11 to 12 years, along with the other adolescent vaccines given at that time.³ Updated recommendations in effect in 2010 state that those at highest risk for meningococcal infection (those with functional or anatomic asplenia, C3 complement deficiency, or HIV infection) should be vaccinated with MCV4 starting at age 2 and revaccinated every 3 years if last vaccinated at 2 to 6 years, and every 5 years if last vaccinated at or after age 7.^4,5 TABLE 1 lists the recommendations for MCV4 in place prior to the October 2010 ACIP meeting.

Two MCV4 products are licensed for use in the United States: Menactra (Sanofi Pasteur) and Menveo (Novartis). Both contain antigens against 4 serotypes, A, C, Y, and W-135. Neither protects against type B, which causes a majority of the disease in infants.⁶ In recent years, serotype A disease has become extremely rare in the United States.⁶ MCV4 coverage for adolescents ages 13 to 17 years is increasing, going from 41.8% in 2008 to 53.6% in 2009.⁷

TABLE 1
Recommendations for MCV4 prior to October 2010^3-5

The new recommendations: One is more controversial than the other

The recommendation for a 2-dose primary series in high-risk groups was not controversial. The same conditions that place individuals at highest risk for meningococcal infection also result in a less robust response to a single dose of the vaccine, and a 2-dose series is needed to achieve protective antibody levels in a high proportion of those vaccine recipients.⁸ This recommendation will affect relatively few patients.

The recommendation for booster doses in the general adolescent population generated a lot more debate. Studies performed since the licensure of MCV4 have shown that levels of protective antibodies decline over time. Five years after vaccination, 50% of vaccine recipients have levels below that considered fully protective.² One small case-control study of 107 cases suggested that the number of years from receipt of the vaccine was a risk factor for meningococcal disease.²

However, rates of meningococcal meningitis in adolescents have been declining over the past few years (TABLE 2), and there are no surveillance data to support the conclusion that teens vaccinated at ages 11 to 12 years are at increased risk as they age. In addition, the number of cases is very low (TABLE 3) and the cost benefit analysis of a booster dose of MCV4 is very unfavorable.^1,2

TABLE 2
Rates* of serogroup C, Y, and W-135 meningococcal disease^†

TABLE 3
Average annual number of cases of C, Y, and W-135 meningococcal disease

ACIP weighed the options for a booster dose
Three options were presented at the October 2010 ACIP meeting:

• Option 1: No change to the current recommendation for vaccination of 11- to 12-year-olds. Wait and see what happens to disease incidence over several more years.
• Option 2: Move the age of vaccination to 15 years with no booster. This would allow protection to persist through the years of highest risk (16-21 years).
• Option 3: Keep the recommendation for vaccination at ages 11 to 12 years, and add a booster dose at age 16.

The first option was the least cost effective: $281,000/quality-adjusted life year (QALY). The second option was the most cost effective at $121,000/QALY. The last option came out in the middle: $157,000/QALY, but it would save the most lives—9 more per year compared with Option 2.¹ There is, however, a caveat with regard to the cost-effectiveness estimates. The numbers were obtained using incidence data from the year 2000; incidence has declined since then, and cost-effectiveness estimates would be much less favorable using today’s rates.

These issues were discussed at length, and the decision to add a booster dose at age 16 was made on a close vote. This decision illustrates how difficult vaccine policy-making has become in recent years, when choices must be made about recommending safe, effective, and expensive vaccines to prevent illnesses that are both rare and serious.

The new MCV4 recommendations will be added to the child immunization schedule for 2011.

The take-home message for family physicians is to strive to increase the proportion of 11- to 12-year-olds who are fully vaccinated and in 2011 to begin to advise those who are between the ages of 16 and 20 years of the recommendation for a booster dose of MCV4.

At its October 2010 meeting, the Advisory Committee on Immunization Practices (ACIP) made 2 additions to its recommendations for quadrivalent meningococcal conjugate vaccine (MCV4), based on evolving knowledge of the vaccine and its duration of protection.

• A booster dose at age 16 has been added to the routine schedule for those vaccinated at ages 11 to 12 years. A booster dose has also been added for those vaccinated at ages 13 to 15 years, although the recommended timing of this booster had not been finalized at press time.
• A 2-dose primary series, 2 months apart, is now recommended for patients at higher risk of meningococcal disease. The high-risk category includes those with persistent complement component deficiency, asplenia, or human immunodeficiency virus (HIV). High-risk patients who were previously vaccinated should receive a booster dose at the earliest opportunity and continue to receive boosters at the appropriate interval (3-5 years).

Meningitis is rare but serious
Meningococcal meningitis is a potentially devastating disease in adolescents and young adults. It has a case fatality rate of about 20%, and the sequelae for survivors can be severe: 3.1% require limb amputations and another 10.9% suffer neurological deficits.¹ Thankfully, meningococcal disease is rare, occurring at rates below 1 in 200,000 in the 11- to 15-year-old age group and less than 1 in 100,000 in the 16- to 21-year-old age group.²

Routine immunization with MCV4 is recommended for adolescents
In 2007, ACIP recommended routine use of MCV4 for adolescents between the ages of 11 and 18 years. The recommendation gave preference to immunization at ages 11 to 12 years, along with the other adolescent vaccines given at that time.³ Updated recommendations in effect in 2010 state that those at highest risk for meningococcal infection (those with functional or anatomic asplenia, C3 complement deficiency, or HIV infection) should be vaccinated with MCV4 starting at age 2 and revaccinated every 3 years if last vaccinated at 2 to 6 years, and every 5 years if last vaccinated at or after age 7.^4,5 TABLE 1 lists the recommendations for MCV4 in place prior to the October 2010 ACIP meeting.

Two MCV4 products are licensed for use in the United States: Menactra (Sanofi Pasteur) and Menveo (Novartis). Both contain antigens against 4 serotypes, A, C, Y, and W-135. Neither protects against type B, which causes a majority of the disease in infants.⁶ In recent years, serotype A disease has become extremely rare in the United States.⁶ MCV4 coverage for adolescents ages 13 to 17 years is increasing, going from 41.8% in 2008 to 53.6% in 2009.⁷

TABLE 1
Recommendations for MCV4 prior to October 2010^3-5

The new recommendations: One is more controversial than the other

The recommendation for a 2-dose primary series in high-risk groups was not controversial. The same conditions that place individuals at highest risk for meningococcal infection also result in a less robust response to a single dose of the vaccine, and a 2-dose series is needed to achieve protective antibody levels in a high proportion of those vaccine recipients.⁸ This recommendation will affect relatively few patients.

The recommendation for booster doses in the general adolescent population generated a lot more debate. Studies performed since the licensure of MCV4 have shown that levels of protective antibodies decline over time. Five years after vaccination, 50% of vaccine recipients have levels below that considered fully protective.² One small case-control study of 107 cases suggested that the number of years from receipt of the vaccine was a risk factor for meningococcal disease.²

However, rates of meningococcal meningitis in adolescents have been declining over the past few years (TABLE 2), and there are no surveillance data to support the conclusion that teens vaccinated at ages 11 to 12 years are at increased risk as they age. In addition, the number of cases is very low (TABLE 3) and the cost benefit analysis of a booster dose of MCV4 is very unfavorable.^1,2

TABLE 2
Rates* of serogroup C, Y, and W-135 meningococcal disease^†

TABLE 3
Average annual number of cases of C, Y, and W-135 meningococcal disease

ACIP weighed the options for a booster dose
Three options were presented at the October 2010 ACIP meeting:

• Option 1: No change to the current recommendation for vaccination of 11- to 12-year-olds. Wait and see what happens to disease incidence over several more years.
• Option 2: Move the age of vaccination to 15 years with no booster. This would allow protection to persist through the years of highest risk (16-21 years).
• Option 3: Keep the recommendation for vaccination at ages 11 to 12 years, and add a booster dose at age 16.

The first option was the least cost effective: $281,000/quality-adjusted life year (QALY). The second option was the most cost effective at $121,000/QALY. The last option came out in the middle: $157,000/QALY, but it would save the most lives—9 more per year compared with Option 2.¹ There is, however, a caveat with regard to the cost-effectiveness estimates. The numbers were obtained using incidence data from the year 2000; incidence has declined since then, and cost-effectiveness estimates would be much less favorable using today’s rates.

These issues were discussed at length, and the decision to add a booster dose at age 16 was made on a close vote. This decision illustrates how difficult vaccine policy-making has become in recent years, when choices must be made about recommending safe, effective, and expensive vaccines to prevent illnesses that are both rare and serious.

The new MCV4 recommendations will be added to the child immunization schedule for 2011.

The take-home message for family physicians is to strive to increase the proportion of 11- to 12-year-olds who are fully vaccinated and in 2011 to begin to advise those who are between the ages of 16 and 20 years of the recommendation for a booster dose of MCV4.

Influenza pandemics like the one we had last year are uncommon, and mounting an effective response was a difficult challenge. The pandemic hit early and hard. Physicians and the public health system responded well, administering a seasonal flu vaccine as well as a new H1N1 vaccine that was approved, produced, and distributed in record time. Before the end of the season, approximately 30% of the population had received an H1N1 vaccine and 40% a seasonal vaccine.¹

What happened last year

The influenza attack rate in 2009-2010 exceeded that of a normal influenza season and the age groups most affected were also different, with those over the age of 65 largely spared.² Virtually all the influenza last year was caused by the pandemic H1N1 strain.² Fortuitously, the virus was not especially virulent and the death rates were below what was initially expected. TABLE 1 lists the population death rates that occurred for different age groups.² Most of the more than 2000 deaths were among those with high-risk conditions.³ Those conditions are listed in TABLE 2.

There were, however, 269 deaths by late March among children, which far exceeded the number of deaths in this age group for the previous 3 influenza seasons.² For the most part, these higher mortality rates were due to higher attack rates, rather than higher case fatality rates. This is evident from hospitalization rates for children younger than age 5, which exceeded those of other age groups, as shown in FIGURE 1.

TABLE 1
2009-2010 Influenza death rates by age

TABLE 2
Individuals at higher risk for influenza complications (or who may spread infection to those at higher risk)

FIGURE 1
Cumulative lab-confirmed hospitalization rate by age group, 2009 H1N1, April 2009-February 13, 2010*

The task will be simpler this year
While it’s not possible to predict what will happen in the upcoming season, 2 developments should simplify the family physician’s task of adhering to official recommendations:

• Only 1 vaccine formulation will be available, and
• For the first time, the recommendation is to vaccinate everyone who does not have a contraindication.⁴

The vaccine for the 2010-2011 season will contain 3 antigens: the pandemic H1N1 virus, an H3N2 A strain (A/Perth/16/2009), and a B virus (B/Brisbane/60/2008).² The decision on which antigens to include is made 6 months in advance of the start of the next flu season and is based on information about the most common influenza antigens circulating worldwide at that time.

Immunization for all

This year’s recommendation to immunize everyone who does not have a contraindication is a major change from the age- and risk-based recommendations of past years. The universal recommendation is the culmination of the incremental expansions of recommendation categories that occurred over the past decade, which resulted in suboptimal immunization rates.¹ In 2009, only 40% to 50% of adults for whom the seasonal vaccine was recommended received it.⁵ While the annual influenza vaccine recommendation is now universal, those who should be specially targeted include those in TABLE 2. Most public health authorities believe children should also receive special emphasis because of the high transmission rate among school-age children and their home contacts. Next, of course, come health care workers, who should be vaccinated to protect ourselves, our families, and our patients.^4,6

Antivirals for treatment and prevention

There are 2 uses for antivirals to combat influenza: treatment of those infected and chemoprevention for those exposed to someone infected. Treatment is recommended for those with confirmed or suspected influenza who have severe, complicated, or progressive illness or who are hospitalized.⁷ Treatment should be strongly considered for anyone at higher risk for complications and death from influenza.⁷

Chemoprevention is now being deemphasized because of a concern for possible development of antiviral resistance. It should be considered for those in the high-risk categories (TABLE 2) with a documented exposure.⁷

Which antiviral to use will depend on which influenza strains are circulating and their resistance patterns. So far, H1N1 has remained largely sensitive to both neuraminidase inhibitors: oseltamivir and zanamivir. However, oseltamivir resistance has been documented in a few cases and will be monitored carefully.

Family physicians will need to stay informed by state and local health departments about circulating strains and resistance patterns. The latest Centers for Disease Control and Prevention (CDC) guidance on antiviral therapy can be consulted for dosage and other details on the 4 antiviral drugs licensed in the United States.⁷

What you must know about vaccine safety

Because of increasing public awareness of safety issues, family physicians will frequently need to address patients’ questions about the safety of this year’s vaccine. Last year, multiple reporting systems including the Vaccine Adverse Event Reporting System (VAERS), Vaccine Safety Datalink (VSD) Project, the Defense Medical Surveillance System (DMSS), and others, extensively monitored adverse events that could potentially be linked to the H1N1 vaccine.⁸ Three so-called weak signals—indications of a possible link to a rare, but statistically significant adverse event—were received.

The 3 signals were for Guillain-Barré syndrome (GBS), Bell’s palsy, and thrombocytopenia/idiopathic thrombocytopenic purpura. The status of the investigation of each potential link to the vaccine can be found on the National Vaccine Advisory Committee (NVAC) safety Web site at http://www.hhs.gov/nvpo/nvac/reports/index.html.

The GBS signal has been investigated the most aggressively because this adverse reaction has been linked to the so-called swine flu vaccine of 1976. One analysis has been published in the Morbidity and Mortality Weekly Report.⁹ Whether GBS has a causal link to the H1N1 vaccine remains in doubt. In the worst-case scenario, if causation is determined, it appears that the vaccine would account for no more than 1 excess case of GBS per million doses.⁹

In Western Australia, there has been a recent report of an excess of fever and febrile seizures in children 6 months to 5 years of age, and fever in children 5 to 9 years of age who received seasonal influenza vaccine. The rate of febrile seizures in children younger than age 3 was 7 per 1000, which is 7 times the rate normally expected. These adverse reactions were associated with only 1 vaccine product, Fluvax, and Fluvax Junior, manufactured by CSL Biotherapies.¹⁰ The CSL product is marketed in the United States by Merck & Co. under the brand name Afluria.

The Advisory Committee on Immunization Practices (ACIP) has issued the following recommendations:¹¹

• Afluria should not be used in children ages 6 months through 8 years. The exception: children who are ages 5 through 8 years who are considered to be at high risk for influenza complications and for whom no other trivalent inactivated vaccine is available.
• Other age-appropriate, licensed seasonal influenza vaccine formulations should be used for prevention of influenza in children ages 6 months through 8 years.

High-dose vaccine for elderly patients

A new seasonal influenza vaccine (Fluzone High-Dose, manufactured by Sanofi Pasteur) is now available for use in people who are 65 years of age and older.¹² Fluzone High-Dose contains 4 times the amount of influenza antigen as other inactivated seasonal influenza vaccines. Fluzone High-Dose vaccine produces higher antibody levels in the elderly but also a higher frequency of local reactions. Studies are being conducted to see if the vaccine results in better patient outcomes. ACIP does not state a preference for any of the available influenza vaccines for those who are 65 years of age and older.¹²

Children younger than age 9: One dose or two?

The new recommendations for deciding if a child under the age of 9 years should receive 1 or 2 doses of the vaccine run counter to the trend for simplification in influenza vaccine recommendations. The decision depends on the child’s past immunization history for both seasonal and H1N1 vaccines. To be fully vaccinated with only 1 dose this year, a child must have previously received at least 1 dose of H1N1 vaccine and 2 doses of seasonal vaccine. FIGURE 2 illustrates the process you need to go through to make the dosage choice. When the child’s immunization history is unknown or uncertain, give 2 doses, separated by 4 weeks.⁴

FIGURE 2
Children younger than 9: Ask 4 questions